This page provides information on organizations recognized by FDA to review submissions under the 510(k) Third Party Review Program (formally, the Accredited Persons Program) and the devices they may review. Product codes eligible to review by a specific 3P510k Review Organization are listed under the following regulations. Devices eligible for review by 3P510k Review Organizations are limited to the product codes shown on the list of eligible devices. You can look up a given product code in the product code database, browse by 3P510k review organization in the list below or browse by device area to confirm eligibility of your device.
As of August 13, 2021, Accelerated Device Approval Services, LLC (ADAS) is no longer recognized to conduct 510(k) Third Party Reviews. For details, see the Accreditation Status section on the 510(k) Third Party Performance Metrics and Accreditation Status page. |
|
|
|
|
|
| Panel | Section Number | Regulation Name / Device Name | Class |
| Anesthesiology |
| |
868.1075 |
Argon gas analyzer. |
II |
| |
868.1150 |
Indwelling blood carbon dioxide partial pressure (PCO2) analyzer. |
II |
| |
868.1170 |
Indwelling blood hydrogen ion concentration (pH) analyzer. |
II |
| |
868.1400 |
Carbon dioxide gas analyzer. |
II |
| |
868.1430 |
Carbon monoxide gas analyzer. |
II |
| |
868.1500 |
Enflurane gas analyzer. |
II |
| |
868.1620 |
Halothane gas analyzer. |
II |
| |
868.1640 |
Helium gas analyzer. |
II |
| |
868.1690 |
Nitrogen gas analyzer. |
II |
| |
868.1700 |
Nitrous oxide gas analyzer. |
II |
| |
868.1720 |
Oxygen gas analyzer. |
II |
| |
868.1730 |
Oxygen uptake computer. |
II |
| |
868.1750 |
Pressure plethysmograph. |
II |
| |
868.1760 |
Volume plethysmograph. |
II |
| |
868.1800 |
Rhinoanemometer. |
II |
| |
868.1840 |
Diagnostic spirometer. |
II |
| |
868.1850 |
Monitoring spirometer. |
II |
| |
868.1860 |
Peak-flow meter for spirometry. |
II |
| |
868.1880 |
Pulmonary-function data calculator. |
II |
| |
868.1890 |
Predictive pulmonary-function value calculator. |
II |
| |
868.1900 |
Diagnostic pulmonary-function interpretation calculator. |
II |
| |
868.2375 |
Breathing frequency monitor. |
II |
| |
868.2385 |
Nitrogen dioxide analyzer. |
II |
| |
868.2600 |
Airway pressure monitor. |
II |
| |
868.2775 |
Electrical peripheral nerve stimulator. |
II |
| |
868.5270 |
Breathing system heater. |
II |
| |
868.5330 |
Breathing gas mixer. |
II |
| |
868.5440 |
Portable oxygen generator. |
II |
| |
868.5470 |
Hyperbaric chamber. |
II |
| |
868.5895 |
Continuous ventilator. |
II |
| |
868.5905 |
Noncontinuous ventilator (IPPB). |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Clinical Chemistry |
| |
862.1340 |
Urinary glucose (nonquantitative) test system. |
II |
| |
862.1345 |
Glucose test system. |
II |
| |
862.1450 |
Lactic acid test system. |
I |
| |
862.1690 |
Thyroid stimulating hormone test system. |
II |
| |
862.1810 |
Vitamin B[bdi1][bdi2] test system. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Cardiovascular |
| |
870.1100 |
Blood pressure alarm. |
II |
| |
870.1110 |
Blood pressure computer. |
II |
| |
870.1130 |
Noninvasive blood pressure measurement system. |
II |
| |
870.1425 |
Programmable diagnostic computer. |
II |
| |
870.1435 |
Single-function, preprogrammed diagnostic computer. |
II |
| |
870.2060 |
Transducer signal amplifier and conditioner. |
II |
| |
870.2100 |
Cardiovascular blood flowmeter. |
II |
| |
870.2300 |
Cardiac monitor (including cardiotachometer and rate alarm). |
II |
| |
870.2320 |
Ballistocardiograph. |
II |
| |
870.2340 |
Electrocardiograph. |
II |
| |
870.2350 |
Electrocardiograph lead switching adaptor. |
II |
| |
870.2370 |
Electrocardiograph surface electrode tester. |
II |
| |
870.2770 |
Impedance plethysmograph. |
II |
| |
870.2780 |
Hydraulic, pneumatic, or photoelectric plethysmographs. |
II |
| |
870.2850 |
Extravascular blood pressure transducer. |
II |
| |
870.2860 |
Heart sound transducer. |
II |
| |
870.2870 |
Catheter tip pressure transducer. |
II |
| |
870.2880 |
Ultrasonic transducer. |
II |
| |
870.2910 |
Radiofrequency physiological signal transmitter and receiver. |
II |
| |
870.2920 |
Telephone electrocardiograph transmitter and receiver. |
II |
| |
870.3640 |
Indirect pacemaker generator function analyzer. |
II |
| |
870.3720 |
Pacemaker electrode function tester. |
II |
| |
870.4410 |
Cardiopulmonary bypass in-line blood gas sensor. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Dental |
| |
872.1745 |
Laser fluorescence caries detection device. |
II |
| |
872.1800 |
Extraoral source x-ray system. |
II |
| |
872.1830 |
Cephalometer. |
II |
| |
872.4200 |
Dental handpiece and accessories. |
I |
| |
872.4850 |
Ultrasonic scaler. |
II |
| |
872.5570 |
Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. |
II |
| |
872.6070 |
Ultraviolet activator for polymerization. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Ear Nose & Throat |
| |
874.1090 |
Auditory impedance tester. |
II |
| |
874.3302 |
Hearing Aid, Bone Conduction |
II |
| |
874.3400 |
Tinnitus masker. |
II |
| |
874.4760 |
Nasopharyngoscope (flexible or rigid) and accessories. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Gastroenterology |
| |
876.1500 |
Endoscope and accessories. |
II |
| |
876.5320 |
Nonimplanted electrical continence device. |
II |
| |
876.5665 |
Water purification system for hemodialysis. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Hematology |
| |
864.5200 |
Automated cell counter. |
II |
| |
864.5220 |
Automated differential cell counter. |
II |
| |
864.5260 |
Automated cell-locating device. |
II |
| |
864.5680 |
Automated heparin analyzer. |
II |
| |
864.6550 |
Occult blood test. |
II |
| |
864.7010 |
Flow Cytometric Test System For Hematopoietic Neoplasms |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| General Hospital |
| |
880.2910 |
Clinical electronic thermometer. |
II |
| |
880.5130 |
Infant radiant warmer. |
II |
| |
880.5400 |
Neonatal incubator. |
II |
| |
880.5410 |
Neonatal transport incubator. |
II |
| |
880.6860 |
Ethylene oxide gas sterilizer. |
II |
| |
880.6870 |
Dry-heat sterilizer. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Immunology |
| |
866.5130 |
Alpha-1-antitrypsin immunological test system. |
II |
| |
866.5340 |
Ferritin immunological test system. |
II |
| |
866.5580 |
Alpha-1-lipoprotein immunological test system. |
II |
| |
866.6010 |
Tumor-associated antigen immunological test system. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Microbiology |
| |
866.2190 |
Microbial Colony Image Assessment System |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Neurology |
| |
882.1420 |
Electroencephalogram (EEG) signal spectrum analyzer. |
I |
| |
882.1460 |
Nystagmograph. |
II |
| |
882.1550 |
Nerve conduction velocity measurement device. |
II |
| |
882.1570 |
Powered direct-contact temperature measurement device. |
II |
| |
882.1620 |
Intracranial pressure monitoring device. |
II |
| |
882.1630 |
Cranial Motion Measurement Device |
II |
| |
882.1835 |
Physiological signal amplifier. |
II |
| |
882.1845 |
Physiological signal conditioner. |
II |
| |
882.1870 |
Evoked response electrical stimulator. |
II |
| |
882.1880 |
Evoked response mechanical stimulator. |
II |
| |
882.1890 |
Evoked response photic stimulator. |
II |
| |
882.1900 |
Evoked response auditory stimulator. |
II |
| |
882.1950 |
Tremor transducer. |
II |
| |
882.4400 |
Radiofrequency lesion generator. |
II |
| |
882.5810 |
External functional neuromuscular stimulator. |
II |
| |
882.5890 |
Transcutaneous electrical nerve stimulator for pain relief. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Obstetrics/Gynecology |
| |
866.6050 |
Ovarian adnexal mass assessment score test system. |
II |
| |
884.1630 |
Colposcope. |
II |
| |
884.2700 |
Intrauterine pressure monitor and accessories. |
II |
| |
884.2720 |
External uterine contraction monitor and accessories. |
II |
| |
884.2740 |
Perinatal monitoring system and accessories. |
II |
| |
884.2960 |
Obstetric ultrasonic transducer and accessories. |
II |
| |
884.4120 |
Gynecologic electrocautery and accessories. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Ophthalmic |
| |
886.1120 |
Ophthalmic camera. |
II |
| |
886.1510 |
Eye movement monitor. |
II |
| |
886.1570 |
Ophthalmoscope. |
II |
| |
886.1850 |
AC-powered slitlamp biomicroscope. |
II |
| |
886.1930 |
Tonometer and accessories. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Pathology |
| |
864.3700 |
Digital Pathology Display |
II |
| |
866.6080 |
Next generation sequencing based tumor profiling test. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Physical Medicine |
| |
890.5300 |
Ultrasonic diathermy. |
II |
| |
890.5525 |
Iontophoresis device. |
II |
| |
890.5850 |
Powered muscle stimulator. |
II |
| |
890.5880 |
Multi-function physical therapy table. |
II |
| |
890.5900 |
Power traction equipment. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Radiology |
| |
892.1000 |
Magnetic resonance diagnostic device. |
II |
| |
892.1100 |
Scintillation (gamma) camera. |
I |
| |
892.1170 |
Bone densitometer. |
II |
| |
892.1200 |
Emission computed tomography system. |
II |
| |
892.1570 |
Diagnostic ultrasonic transducer. |
II |
| |
892.1630 |
Electrostatic x-ray imaging system. |
II |
| |
892.1650 |
Image-intensified fluoroscopic x-ray system. |
II |
| |
892.1710 |
Mammographic x-ray system. |
II |
| |
892.1715 |
Full-field digital mammography system. |
II |
| |
892.1720 |
Mobile x-ray system. |
II |
| |
892.1740 |
Tomographic x-ray system. |
II |
| |
892.1750 |
Computed tomography x-ray system. |
II |
| |
892.2050 |
Picture archiving and communications system. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| General & Plastic Surgery |
| |
878.4400 |
Electrosurgical cutting and coagulation device and accessories. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Toxicology |
| |
862.3035 |
Amikacin test system. |
II |
| |
862.3100 |
Amphetamine test system. |
II |
| |
862.3350 |
Diphenylhydantoin test system. |
II |
| |
862.3360 |
Drug metabolizing enzyme genotyping system. |
II |
| |
862.3580 |
Lysergic acid diethylamide (LSD) test system. |
II |
| |
862.3630 |
Methaqualone test system. |
II |
| |
862.3645 |
Neuroleptic drugs radioreceptor assay test system. |
II |
| |
862.3880 |
Theophylline test system. |
II |
| |
862.3950 |
Vancomycin test system. |
II |
| top of page |
