FDA is considering the following list of devices as exempt from 510k requirements.
The agency continues to emphasize that Class II devices exempt from 510(k) requirements must still meet other US regulatory obligations—including 21 CFR Part 820 Quality System Regulations.
List of Class II devices the FDA is proposing to exempt from the FDA 510(k) process (sorted by Product Code):
21 CFR section | Device type | Product code |
868.1040 | Algesimeter, Powered | BSI |
868.6250 | Compressor, Air, Portable | BTI |
880.5580 | Locator, Acupuncture Point | BWJ |
868.5180 | Bed, Rocking, Breathing Assist | CCO |
862.1700 | Radioimmunoassay, Total Thyroxine | CDX |
862.1685 | Radioimmunoassay, Thyroxine-Binding Globulin | CEE |
862.1445 | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes | CEX |
862.1445 | Electrophoretic, Lactate Dehydrogenase Isoenzymes | CFE |
866.5210 | Immunochemical, Ceruloplasmin | CHN |
862.1100 | Vanillin Pyruvate, AST/SGOT | CIF |
862.1100 | Diazo, AST/SGOT | CIQ |
862.1100 | Hydrazone Colorimetry, AST/SGOT | CIS |
862.1100 | NADH Oxidation/NAD Reduction, AST/SGOT | CIT |
862.1020 | Acid Phosphatase, Nitrophenylphosphate | CJN |
862.1020 | Acid Phosphatase, Thymol Blue Monophosphate | CJR |
862.1020 | Acid Phosphatase, Disodium Phenylphosphate | CJX |
862.1020 | Acid Phosphatase, Naphthyl Phosphate | CKB |
862.1020 | Acid Phosphatase, Thymolphthale Inmonophosphate | CKE |
862.1020 | Acid Phosphatase, Beta Glycerophosphate | CKH |
866.5470 | Hemoglobin, Chain Specific, Antigen, Antiserum, Control | DAM |
866.5210 | Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control | DCT |
866.5210 | Ceruloplasmin, FITC, Antigen, Antiserum, Control | DCY |
866.5210 | Ceruloplasmin, Antigen, Antiserum, Control | DDB |
866.5620 | Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control | DDT |
866.5620 | Alpha-2-Macroglobulin, FITC, Antigen, Antiserum, Control | DDY |
866.5620 | Alpha-2-Macroglobulin, Antigen, Antiserum, Control | DEB |
866.5750 | System, Test, Radioallergosorbent (RAST) Immunological | DHB |
862.3250 | Gas Chromatography, Cocaine | DIN |
862.3250 | Enzyme Immunoassay, Cocaine and Cocaine Metabolites | DIO |
862.3640 | Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep. | DIQ |
862.3250 | Free Radical Assay, Cocaine | DIR |
862.3150 | Enzyme Immunoassay, Barbiturate | DIS |
862.3100 | Thin Layer Chromatography, Amphetamine | DIT |
862.3620 | Hemagglutination Inhibition, Methadone | DIW |
862.3610 | Thin Layer Chromatography, Methamphetamine | DJC |
862.3650 | Gas Chromatography, Opiates | DJF |
862.3650 | Enzyme Immunoassay, Opiates | DJG |
862.3640 | Fluorometry, Morphine | DJJ |
862.3150 | Enzyme Immunoassay, Barbiturate | DJL |
862.3150 | Mercury Dithiazone, Colorimetry, Barbiturate | DJN |
862.3100 | Radioimmunoassay, Amphetamine | DJP |
862.3620 | Enzyme Immunoassay, Methadone | DJR |
862.3200 | Calibrators, Drug Mixture | DKB |
862.3870 | Reagents, Test, Tetrahydrocannabinol | DKE |
862.3150 | Radioimmunoassay, Barbiturate | DKN |
862.3620 | Thin Layer Chromatography, Methadone | DKR |
862.3650 | Free Radical Assay, Opiates | DKT |
862.3150 | Thin Layer Chromatography, Barbiturate | DKX |
862.3100 | Enzyme Immunoassay, Amphetamine | DKZ |
862.3580 | Radioimmunoassay, LSD (125-I) | DLB |
862.3270 | Thin Layer Chromatography, Codeine | DLD |
862.3200 | Calibrators, Drug Specific | DLJ |
862.3250 | Hemagglutination, Cocaine Metabolites (Benzoylecgonine) | DLN |
862.3640 | Hemagglutination Inhibition, Morphine | DLR |
862.3650 | Hemagglutination, Opiates | DLT |
862.3150 | Hemagglutination Inhibition, Barbiturate | DLX |
862.3620 | Gas Chromatography, Methadone | DMB |
862.3150 | Gas Liquid Chromatography, Barbiturate | DMF |
862.3250 | Thin Layer Chromatography, Cocaine | DMN |
862.3640 | Gas Chromatography, Morphine | DMY |
862.3640 | Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody | DNA |
862.3100 | Liquid Chromatography, Amphetamine | DNI |
862.3640 | Thin Layer Chromatography, Morphine | DNK |
862.3200 | Calibrators, Ethyl Alcohol | DNN |
862.3620 | Liquid Chromatography, Methadone | DNT |
862.3100 | Gas Chromatography, Amphetamine | DOD |
862.3640 | Radioimmunoassay, Morphine (123-I), Goat Antibody Ammonium Sulfate Sep. | DOE |
862.3640 | Free Radical Assay, Morphine | DOK |
862.3580 | Free Radical Assay, LSD | DOL |
862.3250 | Thin Layer Chromatography, Benzoylecgonine | DOM |
862.3640 | Liquid Chromatography, Morphine | DPK |
862.3700 | Thin Layer Chromatography, Propoxyphene | DPN |
862.3620 | Free Radical Assay, Methadone | DPP |
870.1330 | Wire, Guide, Catheter | DQX |
870.1390 | Trocar | DRC |
870.2675 | Oscillometer | DRZ |
870.4290 | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL |
870.4400 | Reservoir, Blood, Cardiopulmonary Bypass | DTN |
870.4420 | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | DTS |
870.4340 | Monitor and/or Control, Level Sensing, Cardiopulmonary Bypass | DTW |
870.4430 | Suction Control, Intracardiac, Cardiopulmonary Bypass | DWD |
880.5780 | Stocking, Medical Support (to Prevent Pooling of Blood in Legs) | DWL |
872.1720 | Tester, Pulp | EAT |
872.3300 | Coating, Denture Hydrophilic, Resin | EBE |
872.3560 | Reliner, Denture, Over The Counter | EBP |
892.1900 | Controller, Temperature, Radiographic | EGT |
892.1900 | Dryer, Film, Radiographic | EGW |
892.1900 | Processor, Radiographic-Film, Automatic, Dental | EGY |
872.3540 | Pad, Denture, Over The Counter | EHR |
872.3540 | Cushion, Denture, Over The Counter | EHS |
872.6770 | Syringe, Cartridge | EJI |
872.3600 | Denture Preformed (Partially Prefabricated Denture) | EKO |
872.3590 | Denture, Plastic, Tooth | ELM |
872.3890 | Splint, Endodontic Stabilizing | ELS |
874.3320 | Hearing Aid, Group and Auditory Trainer | EPF |
878.4370 | Drape, Surgical, ENT | ERY |
874.3430 | Mold, Middle-Ear | ETC |
874.1120 | Generator, Electronic Noise (for Audiometric Testing) | ETS |
874.3310 | Calibrator, Hearing Aid/Earphone and Analysis Systems | ETW |
874.1090 | Tester, Auditory Impedance | ETY |
876.5895 | Irrigator, Ostomy | EXD |
876.5010 | Bag, Bile Collecting | EXF |
878.4370 | Drape, Pure Latex Sheet, With Self-Retaining Finger Cot | EYX |
878.4370 | Drape, Urological, Disposable | EYY |
876.5365 | Dilator, Esophageal (Metal Olive) Gastro-Urology | EZM |
876.4770 | Urethrotome | EZO |
876.4270 | Rod, Colostomy | EZP |
876.5365 | Bougie, Esophageal, and Gastrointestinal, Gastro-Urology | FAT |
876.1500 | Endoscopic Magnetic Retriever | FCC |
876.1500 | Light Source, Incandescent, Diagnostic | FCQ |
876.1500 | Light Source, Photographic, Fiberoptic | FCR |
876.4020 | Light, Catheter, Fiberoptic, Glass, Ureteral | FCS |
886.4335 | Headlight, Fiberoptic Focusing | FCT |
876.1500 | Light Source, Fiberoptic, Routine | FCW |
876.5980 | Catheter, Retention, Barium Enema With Bag | FGD |
876.1500 | Carrier, Sponge, Endoscopic | FGS |
876.4400 | Ligator, Hemorrhoidal | FHN |
876.5630 | Catheter, Peritoneal, Long-Term Indwelling | FJS |
876.5820 | Set, Dialyzer Holder | FKI |
876.5630 | Catheter, Peritoneal Dialysis, Single Use | FKO |
876.5630 | System, Peritoneal, Automatic Delivery | FKX |
878.4370 | Pad, Kelly | FNW |
878.4580 | Lamp, Operating-Room | FQP |
878.4580 | Light, Surgical, Instrument | FSQ |
886.4335 | Light, Headband, Surgical | FSR |
878.4580 | Light, Surgical, Floor Standing | FSS |
878.4580 | Light, Surgical, Endoscopic | FSW |
878.4580 | Light, Surgical, Connector | FSX |
878.4580 | Light, Surgical, Ceiling Mounted | FSY |
878.4580 | Light, Surgical, Carrier | FSZ |
878.4580 | Light, Surgical, Accessories | FTA |
878.4580 | Lamp, Surgical | FTD |
878.4580 | Illuminator, Remote | FTG |
878.5070 | Apparatus, Air Handling, Bench | FZG |
878.5070 | Apparatus, Air Handling, Room | FZH |
878.5070 | Apparatus, Air Handling, Enclosure | FZI |
878.4495 | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ |
878.4580 | Lamp, Surgical, Incandescent | GBC |
876.5010 | Catheter, Biliary, Surgical | GCA |
876.1500 | Light Source, Endoscope, Xenon Arc | GCT |
876.1500 | Transformer, Endoscope | GCW |
864.8625 | Standards and Controls, Hemoglobin, Normal and Abnormal | GFS |
864.7340 | Fibrinogen Standard | GFX |
864.5425 | Control, Plasma, Abnormal | GGC |
864.7500 | Acid Hematin | GGF |
864.8625 | Control, White-Cell | GGL |
864.8625 | Control, Hemoglobin | GGM |
864.5425 | Plasma, Coagulation Control | GGN |
864.7720 | Test, Prothrombin Consumption | GGQ |
864.7455 | Stain, Fetal Hemoglobin | GHQ |
864.5400 | Fibrometer | GIE |
864.7375 | Glutathione, Red-Cell | GII |
864.7340 | Plasma, Fibrinogen Control | GIL |
864.5425 | Plasma, Control, Normal | GIZ |
864.8625 | Control, Platelet | GJP |
864.8625 | Control, Red-Cell | GJR |
864.8625 | Control, Hematocrit | GLK |
864.8625 | Mixture, Control, White-Cell and Red-Cell Indices | GLQ |
882.1855 | Encephalogram Telemetry System | GYE |
882.1020 | Analyzer, Rigidity | GZM |
882.1540 | Device, Galvanic Skin Response Measurement | GZO |
892.1820 | Chair, Pneumocephalographic | HBK |
882.1560 | Device, Skin Potential Measurement | HCJ |
884.4400 | Forceps, Obstetrical | HDA |
884.4530 | Tenaculum, Uterine | HDC |
884.4900 | Table, Obstetrical, AC-Powered (and Accessories) | HDD |
884.1630 | Colposcope (and Colpomicroscope) | HEX |
884.3200 | Drain, Cervical | HFL |
884.4530 | Clamp, Umbilical | HFW |
884.5390 | Heater, Perineal, Direct Contact | HGZ |
884.5390 | Heater, Perineal, Radiant, Non-Contact | HHA |
884.5400 | Cup, Menstrual | HHE |
884.5425 | Pad, Menstrual, Scented | HHL |
884.4900 | Table, Obstetrical, Manual (and Accessories) | HHP |
884.4530 | Speculum, Vaginal, Nonmetal | HIB |
884.4530 | Speculum, Vaginal, Nonmetal, Fiberoptic | HIC |
886.1945 | Transilluminator, AC-Powered | HJM |
886.1850 | Biomicroscope, Slit-Lamp, AC-Powered | HJO |
886.1780 | Retinoscope, AC-Powered | HKL |
886.1570 | Ophthalmoscope, AC-Powered | HLI |
886.1570 | Ophthalmoscope, Battery-Powered | HLJ |
886.1250 | Euthyscope, AC-Powered | HMK |
878.4370 | Drape, Patient, Ophthalmic | HMT |
878.4370 | Drape, Microscope, Ophthalmic | HMW |
886.4790 | Sponge, Ophthalmic | HOZ |
886.4400 | Locator, Metal, Electronic | HPM |
886.4440 | Magnet, AC-Powered | HPO |
886.4335 | Headlamp, Operating, AC-Powered | HPQ |
886.4250 | Unit, Electrolysis, AC-Powered, Ophthalmic | HRO |
890.1450 | Hammer, Reflex, Powered | IKO |
890.5100 | Bath, Hydro-Massage | ILJ |
890.5100 | Bath, Sitz, Powered | ILM |
890.5500 | Lamp, Infrared, Therapeutic Heating | ILY |
890.5250 | Cabinet, Moist Steam | IMB |
890.5110 | Bath, Paraffin | IMC |
890.5575 | Device, Warning, Overload, External Limb, Powered | IRN |
890.5360 | Exerciser, Measuring | ISD |
892.1850 | Cassette, Radiographic Film | IXA |
892.1670 | Device, Spot-Film | IXL |
892.1900 | Processor, Radiographic-Film, Automatic | IXW |
892.1900 | Processor, Cine Film | IXX |
892.1870 | Programmer, Changer, Film/Cassette, Radiographic | IZP |
892.1610 | Aperature, Radiographic | IZS |
892.1610 | Cone, Radiographic | IZT |
892.1610 | Collimator, Automatic, Radiographic | IZW |
892.1610 | Collimator, Manual, Radiographic | IZX |
868.2550 | Pneumotachometer | JAX |
864.7300 | Fibrin Monomer Paracoagulation | JBN |
864.7275 | Test, Euglobulin Lysis | JBO |
864.5400 | Timer, Coagulation | JBT |
864.6650 | Study, Platelet Adhesive | JBZ |
864.7415 | Control, Hemoglobin, Abnormal | JCM |
864.8625 | Control, Cell Counter, Normal and Abnormal | JCN |
888.4580 | Instrument, Surgical, Sonic and Accessory/Attachment | JDX |
862.1020 | Acid Phosphatase (Prostatic), Tartrate Inhibited | JFH |
866.5210 | P-Phenyl-Enediamine/EDTA (Spectrophotometric), Ceruloplasmin | JFQ |
866.5210 | Indirect Copper Assay, Ceruloplasmin | JFR |
862.1445 | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes | JGF |
862.1150 | Calibrator, Primary | JIS |
862.1150 | Calibrator, Secondary | JIT |
862.1150 | Calibrator, Surrogate | JIW |
862.1150 | Calibrator, Multi-Analyte Mixture | JIX |
864.7375 | Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase | JMH |
864.7735 | Prothrombin-Proconvertin and Thrombotest | JPF |
864.8625 | Mixture, Hematology Quality Control | JPK |
862.3170 | Enzyme Immunoassay, Benzodiazepine | JXM |
862.3700 | Enzyme Immunoassay, Propoxyphene | JXN |
862.3250 | Enzyme Immunoassay, Cocaine | JXO |
866.5630 | System, Test, Beta-2-Microglobulin Immunological | JZG |
876.1500 | Scissors For Cystoscope | KGD |
878.4370 | Ring (Wound Protector), Drape Retention, Internal | KGW |
874.3330 | Hearing Aid, Master | KHL |
872.5550 | Ring, Teething, Fluid-Filled | KKO |
878.4370 | Drape, Surgical | KKX |
862.1700 | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI |
868.2500 | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | KLK |
862.3250 | Radioimmunoassay, Cocaine Metabolite | KLN |
874.1325 | Electroglottograph | KLX |
884.4900 | Table, Obstetric (and Accessories) | KNC |
884.5390 | Heater, Perineal | KND |
876.5365 | Dilator, Esophageal | KNQ |
876.5520 | Dilator, Urethral | KOE |
892.1610 | Device, Beam Limiting, X-Ray, Diagnostic | KPW |
892.1860 | Changer, Radiographic Film/Cassette | KPX |
864.7375 | Assay, Glutathione Reductase | KQF |
862.1090 | Radioassay, Angiotensin Converting Enzyme | KQN |
870.4280 | Filter, Prebypass, Cardiopulmonary Bypass | KRJ |
864.8150 | Calibrator for Cell Indices | KRX |
864.8175 | Calibrator for Platelet Counting | KRY |
864.8165 | Calibrator for Hemoglobin and Hematocrit Measurement | KRZ |
864.8185 | Calibrator for Red-Cell and White-Cell Counting | KSA |
864.9400 | Solution, Stabilized Enzyme | KSK |
862.3630 | Radioimmunoassay, Methaqualone | KXS |
862.3150 | High Pressure Liquid Chromatography, Barbiturate | KZY |
862.3170 | Gas Chromatography, Benzodiazepine | KZZ |
862.3170 | High Pressure Liquid Chromatography, Benzodiazepine | LAA |
862.3170 | Thin Layer Chromatography, Benzodiazepine | LAB |
862.3250 | High Pressure Liquid Chromatography, Cocaine and Cocaine Metabolites | LAC |
862.3270 | Gas Chromatography, Codeine | LAD |
862.3270 | High Pressure Liquid Chromatography, Codeine | LAE |
862.3610 | Gas Chromatography, Methamphetamine | LAF |
862.3610 | High Pressure Liquid Chromatography, Methamphetamine | LAG |
862.3650 | High Pressure Liquid Chromatography, Opiates | LAH |
862.3650 | Thin Layer Chromatography, Opiates | LAI |
862.3700 | Gas Chromatography, Propoxyphene | LAJ |
862.3700 | High Pressure Liquid Chromatography, Propoxyphene | LAK |
862.3870 | Radioimmunoassay, Cannabinoid(S) | LAT |
888.1240 | Dynamometer, AC-Powered | LBB |
862.3870 | Enzyme Immunoassay, Cannabinoids | LDJ |
862.3910 | U.V. Spectrometry, Tricyclic Antidepressant Drugs | LFH |
862.3910 | High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs | LFI |
868.1400 | Legging, Compression, Non-Inflatable | LLK |
892.2030 | Digitizer, Image, Radiological | LMA |
892.2040 | Camera, Multi Format, Radiological | LMC |
868.2500 | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | LPP |
862.1509 | System, Test, Urinary Methylmalonic Acid | LPT |
876.4500 | Lithotriptor, Biliary Mechanical | LQC |
874.3320 | Device, Assistive Listening | LZI |
888.4580 | System, Cement Removal Extraction | LZV |
870.1650 | Syringe, Balloon Inflation | MAV |
874.3730 | Device, Voice Amplification | MCK |
862.3910 | Thin Layer Chromatography, Tricyclic Antidepressant Drugs | MLK |
886.1120 | Photorefractor | MMF |
876.4400 | Ligator, Esophageal | MND |
870.2770 | Analyzer, Body Composition | MNW |
884.6120 | Accessory, Assisted Reproduction | MQG |
884.6130 | Microtools, Assisted Reproduction (Pipettes) | MQH |
884.6150 | Micromanipulators and Microinjectors, Assisted Reproduction | MQJ |
884.6160 | Labware, Assisted Reproduction | MQK |
886.3320 | Ocular Peg | MQU |
880.5580 | Needle, Acupuncture, Single Use | MQX |
868.2385 | Analyzer, Nitrogen Dioxide | MRQ |
862.1345 | Drink, Glucose Tolerance | MRV |
886.1570 | Ophthalmoscopes, Replacement Batteries, Hand-Held | MSG |
886.4150 | Tubing, Replacement, Phacofragmentation Unit | MSR |
874.1090 | Tympanometer | NAS |
884.4530 | Clamp and Cutter, Umbilical | NBZ |
892.2030 | Digitizer, Images, Ophthalmic | NFH |
892.2040 | Device, Hardcopy, Images, Ophthalmic | NFI |
862.3170 | Test, Benzodiazepine, Over The Counter | NFV |
862.3610 | Test, Methamphetamine, Over The Counter | NGG |
884.2990 | Sheet, Recording, Breast Examination | NHM |
876.5665 | Disinfectant, Subsystem, Water Purification | NIH |
864.8625 | Material, Quality Control, Semen Analysis | NRF |
864.8625 | Control Material, Blood Circulating Epithelial Cancer Cell | NRS |
862.2570 | Instrumentation For Clinical Multiplex Test Systems | NSU |
876.1500 | LED Light Source | NTN |
866.5910 | Quality Control Material, Genetics, DNA | NZB |
870.1875 | Lung Sound Monitor | OCR |
876.1500 | Endoscopic Guide Wire, Gastroenterology-Urology | OCY |
876.1500 | Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ |
892.1650 | Arthrogram Tray | OII |
892.1560 | Biopsy Needle Guide Kit | OIJ |
892.1650 | Radiology Dental Tray | OIK |
892.1730 | Discography Kit | OIL |
892.1000 | MRI Disposable Kit | OIM |
892.5730 | Prostate Seeding Kit | OIN |
892.1680 | Radiographic Contrast Tray | OIO |
892.1680 | Radiology Diagnostic Kit | OIP |
886.4790 | Eye Tray | OJK |
884.5200 | Hemorrhoid Prevention Pressure Wedge | OOA |
862.2570 | Real Time Nucleic Acid Amplification System | OOI |
864.6550 | Control, Fecal Occult Blood | OSL |
862.2570 | Mass Spectrometer For Clinical Multiplex Test Systems | OTA |
866.3395 | Norovirus Serological Reagents | OUC |
862.2570 | Micro Total Analysis Instrument System | OUE |
862.2570 | Complete Gene Expression Profiling Accessory Reagents | OVA |
882.5895 | Vibratory Counter-Stimulation | OVP |
862.2570 | DNA Genetic Analyzer | PCA |
862.2265 | High Throughput DNA Sequence Analyzer | PFF |
876.5025 | Vibrator for Climax Control of Premature Ejaculation | PIA |
862.1350 | Continuous Glucose Monitor Secondary Display | PJT |
886.1120 | Camera, Ophthalmic, General-Use | PJZ |
882.1470 | Computerized Cognitive Assessment Aid | PKQ |
876.5980 | Gastrostomy Tube Holder | PLI |
872.3260 | External Cleaning Solution | PME |
862.2570 | Data Acquisition Software | PQQ |