Possible exemption of 337 devices from FDA 510k requirements

Posted on March 21, 2017 · Posted in FDA Regulatory Updates, Medical Device Trends

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