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U.S. Department of Health and Human Services

List of Devices for Third Party Review

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Database updated May 27, 2024

This page lists devices currently eligible for third-party review under the FDA's 510(k) Third Party Review Program, formally, the Accredited Persons Program. Premarket Notifications ["510(k)'s"] for devices on this list can be submitted to FDA-recognized 3P510K Review Organizations (Accredited Persons) in lieu of FDA. Information on the 510(k) Third Party Review Program, including links to this page and to a list of accredited persons, is available at the 510(k) Third Party Review Program website.

How to use the list of eligible devices

The list has four columns:

  • The first column provides the classification regulation number for each device from Title 21, Code of Federal Regulations (CFR), Parts 862-892. A classification regulation identifies a generic type of device and specifies the regulatory class that fda has assigned to the device.
  • The second and third columns show the classification name for the device from the CFR, and the class of the device, respectively. In the second column, under each classification regulation name, one or more 3-letter product codes appear, along with the device name associated with each product code. Product codes represent specific subsets of devices grouped under the same classification regulation name. Manufacturers should determine the classification of their device at the product code level that most appropriately identifies their device(s).
  • The fourth column provides a link to available standards to assist manufacturers in the preparation-and 3P510k review organizations in the review-of 510(k)s for eligible devices.

Some important exceptions to the list

Please see the 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations for exceptions to the list.


Cardiovascular

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Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
870.1100 Blood pressure alarm.    
  DSJ -  Alarm, Blood-Pressure II
870.1110 Blood pressure computer.    
  DSK -  Computer, Blood-Pressure II
870.1120 Blood pressure cuff.    
  DXQ -  Blood Pressure Cuff II
  NPP -  Reprocessed Blood Pressure Cuff II
  OED -  Antimicrobial Blood Pressure Cuff II
870.1130 Noninvasive blood pressure measurement system.    
  DXN -  System, Measurement, Blood-Pressure, Non-Invasive II
870.1140 Venous blood pressure manometer.    
  KRK -  Manometer, Blood-Pressure, Venous II
870.1200 Diagnostic intravascular catheter.    
  DQO -  Catheter, Intravascular, Diagnostic II
870.1210 Continuous flush catheter.    
  KRA -  Catheter, Continuous Flush II
870.1230 Fiberoptic oximeter catheter.    
  DQE -  Catheter, Oximeter, Fiber-Optic II
870.1240 Flow-directed catheter.    
  DYG -  Catheter, Flow Directed II
870.1250 Percutaneous catheter.    
  DQY -  Catheter, Percutaneous II
  LIT -  Catheter, Angioplasty, Peripheral, Transluminal II
  NVM -  Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon II
  QJP -  Catheter, Percutaneous, Neurovasculature II
870.1270 Intracavitary phonocatheter system.    
  DXW -  System, Phonocatheter, Intracavitary II
870.1280 Steerable catheter.    
  DRA -  Catheter, Steerable II
  NKS -  Catheter, Steerable, Reprocessed II
870.1290 Steerable catheter control system.    
  DXX -  System, Catheter Control, Steerable II
  NKR -  System, Catheter Control, Reprocessed II
870.1300 Catheter cannula.    
  DQR -  Cannula, Catheter II
870.1310 Vessel dilator for percutaneous catheterization.    
  DRE -  Dilator, Vessel, For Percutaneous Catheterization II
870.1330 Catheter guide wire.    
  DQX -  Wire, Guide, Catheter II
  MOF -  Guide, Wire, Catheter, Neurovasculature II
870.1340 Catheter introducer.    
  DYB -  Introducer, Catheter II
870.1370 Catheter tip occluder.    
  DQT -  Occluder, Catheter Tip II
870.1380 Catheter stylet.    
  DRB -  Stylet, Catheter II
870.1390 Trocar.    
  NMK -  Trocar, Reprocessed II
870.1425 Programmable diagnostic computer.    
  DQK -  Computer, Diagnostic, Programmable II
870.1435 Single-function, preprogrammed diagnostic computer.    
  DXG -  Computer, Diagnostic, Pre-Programmed, Single-Function II
870.1450 Densitometer.    
  DXM -  Densitometer II
870.1650 Angiographic injector and syringe.    
  MAV -  Syringe, Balloon Inflation II
  NKU -  Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed II
  DXT -  Injector And Syringe, Angiographic II
  IZQ -  Injector, Contrast Medium, Automatic II
  NKP -  Injector, Contrast Medium, Automatic, Reprocessed II
  NKT -  Injector And Syringe, Angiographic, Reprocessed II
870.1660 Indicator injector.    
  DXL -  Injector, Indicator II
870.1670 Syringe actuator for an injector.    
  NKW -  Actuator, Syringe, For Injector, Reprocessed II
  DQF -  Actuator, Syringe, Injector Type II
870.1800 Withdrawal-infusion pump.    
  DQI -  Withdrawal/Infusion Pump II
870.1875 Stethoscope.    
  DQD -  Stethoscope, Electronic II
870.1915 Thermodilution probe.    
  KRB -  Probe, Thermodilution II
870.2050 Biopotential amplifier and signal conditioner.    
  DRR -  Amplifier And Signal Conditioner, Biopotential II
870.2060 Transducer signal amplifier and conditioner.    
  DRQ -  Amplifier And Signal Conditioner, Transducer Signal II
870.2100 Cardiovascular blood flowmeter.    
  DPW -  Flowmeter, Blood, Cardiovascular II
870.2120 Extravascular blood flow probe.    
  DPT -  Probe, Blood-Flow, Extravascular II
870.2300 Cardiac monitor (including cardiotachometer and rate alarm).    
  DRT -  Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) II
  MWI -  Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) II
870.2310 Apex cardiograph (vibrocardiograph).    
  DQH -  Cardiograph, Apex (Vibrocardiograph) II
870.2320 Ballistocardiograph.    
  DXR -  Ballistocardiograph II
870.2330 Echocardiograph.    
  DXK -  Echocardiograph II
870.2340 Electrocardiograph.    
  DPS -  Electrocardiograph II
  MLC -  Monitor, St Segment II
870.2350 Electrocardiograph lead switching adaptor.    
  DRW -  Adaptor, Lead Switching, Electrocardiograph II
870.2370 Electrocardiograph surface electrode tester.    
  KRC -  Tester, Electrode, Surface, Electrocardiographic II
870.2400 Vectorcardiograph.    
  DYC -  Vectorcardiograph II
870.2450 Medical cathode-ray tube display.    
  DXJ -  Display, Cathode-Ray Tube, Medical II
870.2700 Oximeter.    
  NLF -  Oximeter, Reprocessed II
  NMD -  Oximeter, Tissue Saturation, Reprocessed II
  MUD -  Oximeter, Tissue Saturation II
870.2750 Impedance phlebograph.    
  DQB -  Phlebograph, Impedance II
870.2770 Impedance plethysmograph.    
  DSB -  Plethysmograph, Impedance II
  OMV -  Ultrasonic Body Composition Analyzer II
  OAC -  Plethysmograph, Air Displacement For Body Composition Analysis II
870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.    
  JOM -  Plethysmograph, Photoelectric, Pneumatic Or Hydraulic II
870.2800 Medical magnetic tape recorder.    
  DSH -  Recorder, Magnetic Tape, Medical II
870.2840 Apex cardiographic transducer.    
  JON -  Transducer, Apex Cardiographic II
870.2850 Extravascular blood pressure transducer.    
  DRS -  Transducer, Blood-Pressure, Extravascular II
870.2860 Heart sound transducer.    
  JOO -  Transducer, Heart Sound II
870.2870 Catheter tip pressure transducer.    
  DXO -  Transducer, Pressure, Catheter Tip II
870.2880 Ultrasonic transducer.    
  JOP -  Transducer, Ultrasonic II
870.2890 Vessel occlusion transducer.    
  DXP -  Transducer, Vessel Occlusion II
870.2900 Patient transducer and electrode cable (including connector).    
  DSA -  Cable, Transducer And Electrode, Patient, (Including Connector) II
870.2910 Radiofrequency physiological signal transmitter and receiver.    
  DRG -  Transmitters And Receivers, Physiological Signal, Radiofrequency II
870.2920 Telephone electrocardiograph transmitter and receiver.    
  DXH -  Transmitters And Receivers, Electrocardiograph, Telephone II
870.3630 Pacemaker generator function analyzer.    
  DTC -  Analyzer, Pacemaker Generator Function II
870.3640 Indirect pacemaker generator function analyzer.    
  KRE -  Analyzer, Pacemaker Generator Function, Indirect II
870.3720 Pacemaker electrode function tester.    
  DTA -  Tester, Pacemaker Electrode Function II
870.4075 Endomyocardial biopsy device.    
  DWZ -  Device, Biopsy, Endomyocardial II
870.4205 Cardiopulmonary bypass bubble detector.    
  KRL -  Detector, Bubble, Cardiopulmonary Bypass II
870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.    
  DWF -  Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass II
870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.    
  JOD -  Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass II
870.4310 Cardiopulmonary bypass coronary pressure gauge.    
  DXS -  Gauge, Pressure, Coronary, Cardiopulmonary Bypass II
870.4330 Cardiopulmonary bypass on-line blood gas monitor.    
  DRY -  Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass II
870.4390 Cardiopulmonary bypass pump tubing.    
  DWE -  Tubing, Pump, Cardiopulmonary Bypass II
870.4400 Cardiopulmonary bypass blood reservoir.    
  DTN -  Reservoir, Blood, Cardiopulmonary Bypass II
  MJJ -  Cpb Check Valve, Retrograde Flow, In-Line II
870.4410 Cardiopulmonary bypass in-line blood gas sensor.    
  DTY -  Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass II
870.4450 Vascular clamp.    
  DXC -  Clamp, Vascular II
  MJN -  Catheter, Intravascular Occluding, Temporary II
  NMF -  Clamp, Vascular, Reprocessed II
870.4475 Surgical vessel dilator.    
  DWP -  Dilator, Vessel, Surgical II
870.4500 Cardiovascular surgical instruments.    
  NQG -  Stabilizer, Heart, Non-Compression, Reprocessed I
870.4875 Intraluminal artery stripper.    
  DWX -  Stripper, Artery, Intraluminal II
  MCW -  Catheter, Peripheral, Atherectomy II
870.4885 External vein stripper.    
  DWQ -  Stripper, Vein, External II
  MGZ -  Valvulotome II
870.5050 Patient care suction apparatus.    
  DWM -  Apparatus, Suction, Patient Care II
870.5150 Embolectomy catheter.    
  DXE -  Catheter, Embolectomy II
  MMX -  Device, Percutaneous Retrieval II
870.5175 Septostomy catheter.    
  DXF -  Catheter, Septostomy II
870.5325 Defibrillator tester.    
  DRL -  Tester, Defibrillator II
870.5800 Compressible limb sleeve.    
  JOW -  Sleeve, Limb, Compressible II
  PPS -  Sleeve, Head And Neck, Compressible II
870.5900 Thermal regulating system.    
  DWJ -  System, Thermal Regulating II
  NZE -  Hyperthermia Monitor II
870.5910 Esophageal thermal regulation device.    
  PLA -  Esophageal Thermal Regulation And Gastric Suctioning Device II
870.5925 Automatic rotating tourniquet.    
  DRP -  Tourniquet, Automatic Rotating II

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