Current List of FDA-Recognized 510(k) Third Party Review Organizations

Database updated June 22, 2026

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.

Aabb	Beanstock Consulting
Center For Measurement Standards of Industrial	Cola, Inc.
Global Quality and Regulatory Services	Regulatory Technology Services, LLC
Scarlet NB B.V	SMO India
Third Party Review Group, LLC

Scarlet NB B.V

9507 Meadowbrook Avenue

Philadelphia PA 19118    

Panel

Section Number

       Regulation Name / Device Name      

Class

Anesthesiology

868.1730

Oxygen uptake computer.

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

868.2600

Airway pressure monitor.

II

868.5690

Incentive spirometer.

II

Panel

Section Number

       Regulation Name / Device Name      

Class

Cardiovascular

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

870.1875

Stethoscope.

II

870.2300

Cardiac monitor (including cardiotachometer and rate alarm).

II

870.2330

Echocardiograph.

II

870.2340

Electrocardiograph.

II

870.2450

Medical cathode-ray tube display.

II

870.2700

Oximeter.

II

870.2780

Hydraulic, pneumatic, or photoelectric plethysmographs.

II

870.2910

Radiofrequency physiological signal transmitter and receiver.

II

870.2920

Telephone electrocardiograph transmitter and receiver.

II

870.3630

Pacemaker generator function analyzer.

II

870.3720

Pacemaker electrode function tester.

II

870.5600

Adjunctive Open Loop Fluid Therapy Recommender

II

Panel

Section Number

       Regulation Name / Device Name      

Class

Dental

872.1800

Extraoral source x-ray system.

II

872.4120

Bone cutting instrument and accessories.

II

Panel

Section Number

       Regulation Name / Device Name      

Class

Gastroenterology

876.1500

Endoscope and accessories.

II

876.4480

Electrohydraulic lithotriptor.

II

876.5320

Nonimplanted electrical continence device.

II

Panel

Section Number

       Regulation Name / Device Name      

Class

Hematology

864.5200

Automated cell counter.

II

864.5260

Automated cell-locating device.

II

864.5400

Coagulation instrument.

II

864.5680

Automated heparin analyzer.

II

864.5700

Automated platelet aggregation system.

II

864.6550

Occult blood test.

II

864.7500

Whole blood hemoglobin assays.

II

Panel

Section Number

       Regulation Name / Device Name      

Class

Neurology

882.1320

Cutaneous electrode.

II

882.1350

Needle electrode.

II

882.1400

Electroencephalograph.

II

882.1420

Electroencephalogram (EEG) signal spectrum analyzer.

I

882.1550

Nerve conduction velocity measurement device.

II

882.1620

Intracranial pressure monitoring device.

II

882.1870

Evoked response electrical stimulator.

II

882.1890

Evoked response photic stimulator.

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

884.2225

Obstetric-gynecologic ultrasonic imager.

II

884.2675

Fetal scalp circular (spiral) electrode and applicator.

II

Panel

Section Number

       Regulation Name / Device Name      

Class

Ophthalmic

886.1120

Ophthalmic camera.

II

886.1300

Afterimage flasher.

II

886.1360

Visual field laser instrument.

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

890.1385

Diagnostic electromyograph needle electrode.

II

890.5850

Powered muscle stimulator.

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

892.1550

Ultrasonic pulsed doppler imaging system.

II

892.1560

Ultrasonic pulsed echo imaging system.

II

892.1650

Image-intensified fluoroscopic x-ray system.

II

892.1660

Non-image-intensified fluoroscopic x-ray system.

II

892.1680

Stationary x-ray system.

II

892.1720

Mobile x-ray system.

II

892.1730

Photofluorographic 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

892.5840

Radiation therapy simulation system.

II

Panel

Section Number

       Regulation Name / Device Name      

Class

General & Plastic Surgery

878.4580

Surgical lamp.

II

878.4810

Laser surgical instrument for use in general and plastic surgery and in dermatology.

II