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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 November 29, 2021

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. II  
  DSJ -  Alarm, Blood-Pressure  
870.1110 Blood pressure computer. II  
  DSK -  Computer, Blood-Pressure  
870.1120 Blood pressure cuff. II  
  DXQ -  Blood Pressure Cuff  
  NPP -  Reprocessed Blood Pressure Cuff  
  OED -  Antimicrobial Blood Pressure Cuff  
870.1130 Noninvasive blood pressure measurement system. II  
  DXN -  System, Measurement, Blood-Pressure, Non-Invasive  
870.1140 Venous blood pressure manometer. II  
  KRK -  Manometer, Blood-Pressure, Venous  
870.1200 Diagnostic intravascular catheter. II  
  DQO -  Catheter, Intravascular, Diagnostic  
870.1210 Continuous flush catheter. II  
  KRA -  Catheter, Continuous Flush  
870.1230 Fiberoptic oximeter catheter. II  
  DQE -  Catheter, Oximeter, Fiber-Optic  
870.1240 Flow-directed catheter. II  
  DYG -  Catheter, Flow Directed  
870.1250 Percutaneous catheter. II  
  DQY -  Catheter, Percutaneous  
  LIT -  Catheter, Angioplasty, Peripheral, Transluminal  
  NVM -  Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon  
  QJP -  Catheter, Percutaneous, Neurovasculature  
870.1270 Intracavitary phonocatheter system. II  
  DXW -  System, Phonocatheter, Intracavitary  
870.1280 Steerable catheter. II  
  DRA -  Catheter, Steerable  
  NKS -  Catheter, Steerable, Reprocessed  
870.1290 Steerable catheter control system. II  
  DXX -  System, Catheter Control, Steerable  
  NKR -  System, Catheter Control, Reprocessed  
870.1300 Catheter cannula. II  
  DQR -  Cannula, Catheter  
870.1310 Vessel dilator for percutaneous catheterization. II  
  DRE -  Dilator, Vessel, For Percutaneous Catheterization  
870.1330 Catheter guide wire. II  
  DQX -  Wire, Guide, Catheter  
  MOF -  Guide, Wire, Catheter, Neurovasculature  
870.1340 Catheter introducer. II  
  DYB -  Introducer, Catheter  
870.1370 Catheter tip occluder. II  
  DQT -  Occluder, Catheter Tip  
870.1380 Catheter stylet. II  
  DRB -  Stylet, Catheter  
870.1390 Trocar. II  
  NMK -  Trocar, Reprocessed  
870.1425 Programmable diagnostic computer. II  
  DQK -  Computer, Diagnostic, Programmable  
870.1435 Single-function, preprogrammed diagnostic computer. II  
  DXG -  Computer, Diagnostic, Pre-Programmed, Single-Function  
870.1450 Densitometer. II  
  DXM -  Densitometer  
870.1650 Angiographic injector and syringe. II  
  MAV -  Syringe, Balloon Inflation  
  NKU -  Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed  
  DXT -  Injector And Syringe, Angiographic  
  IZQ -  Injector, Contrast Medium, Automatic  
  NKP -  Injector, Contrast Medium, Automatic, Reprocessed  
  NKT -  Injector And Syringe, Angiographic, Reprocessed  
870.1660 Indicator injector. II  
  DXL -  Injector, Indicator  
870.1670 Syringe actuator for an injector. II  
  NKW -  Actuator, Syringe, For Injector, Reprocessed  
  DQF -  Actuator, Syringe, Injector Type  
870.1800 Withdrawal-infusion pump. II  
  DQI -  Withdrawal/Infusion Pump  
870.1875 Stethoscope. II  
  DQD -  Stethoscope, Electronic  
870.1915 Thermodilution probe. II  
  KRB -  Probe, Thermodilution  
870.2050 Biopotential amplifier and signal conditioner. II  
  DRR -  Amplifier And Signal Conditioner, Biopotential  
870.2060 Transducer signal amplifier and conditioner. II  
  DRQ -  Amplifier And Signal Conditioner, Transducer Signal  
870.2100 Cardiovascular blood flowmeter. II  
  DPW -  Flowmeter, Blood, Cardiovascular  
870.2120 Extravascular blood flow probe. II  
  DPT -  Probe, Blood-Flow, Extravascular  
870.2300 Cardiac monitor (including cardiotachometer and rate alarm). II  
  DRT -  Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)  
  MWI -  Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)  
870.2310 Apex cardiograph (vibrocardiograph). II  
  DQH -  Cardiograph, Apex (Vibrocardiograph)  
870.2320 Ballistocardiograph. II  
  DXR -  Ballistocardiograph  
870.2330 Echocardiograph. II  
  DXK -  Echocardiograph  
870.2340 Electrocardiograph. II  
  DPS -  Electrocardiograph  
  MLC -  Monitor, St Segment  
870.2350 Electrocardiograph lead switching adaptor. II  
  DRW -  Adaptor, Lead Switching, Electrocardiograph  
870.2370 Electrocardiograph surface electrode tester. II  
  KRC -  Tester, Electrode, Surface, Electrocardiographic  
870.2400 Vectorcardiograph. II  
  DYC -  Vectorcardiograph  
870.2450 Medical cathode-ray tube display. II  
  DXJ -  Display, Cathode-Ray Tube, Medical  
870.2700 Oximeter. II  
  NLF -  Oximeter, Reprocessed  
  MUD -  Oximeter, Tissue Saturation  
  NMD -  Oximeter, Tissue Saturation, Reprocessed  
870.2750 Impedance phlebograph. II  
  DQB -  Phlebograph, Impedance  
870.2770 Impedance plethysmograph. II  
  DSB -  Plethysmograph, Impedance  
  OMV -  Ultrasonic Body Composition Analyzer  
  OAC -  Plethysmograph, Air Displacement For Body Composition Analysis  
870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs. II  
  JOM -  Plethysmograph, Photoelectric, Pneumatic Or Hydraulic  
870.2800 Medical magnetic tape recorder. II  
  DSH -  Recorder, Magnetic Tape, Medical  
870.2840 Apex cardiographic transducer. II  
  JON -  Transducer, Apex Cardiographic  
870.2850 Extravascular blood pressure transducer. II  
  DRS -  Transducer, Blood-Pressure, Extravascular  
870.2860 Heart sound transducer. II  
  JOO -  Transducer, Heart Sound  
870.2870 Catheter tip pressure transducer. II  
  DXO -  Transducer, Pressure, Catheter Tip  
870.2880 Ultrasonic transducer. II  
  JOP -  Transducer, Ultrasonic  
870.2890 Vessel occlusion transducer. II  
  DXP -  Transducer, Vessel Occlusion  
870.2900 Patient transducer and electrode cable (including connector). II  
  DSA -  Cable, Transducer And Electrode, Patient, (Including Connector)  
870.2910 Radiofrequency physiological signal transmitter and receiver. II  
  DRG -  Transmitters And Receivers, Physiological Signal, Radiofrequency  
870.2920 Telephone electrocardiograph transmitter and receiver. II  
  DXH -  Transmitters And Receivers, Electrocardiograph, Telephone  
870.3630 Pacemaker generator function analyzer. II  
  DTC -  Analyzer, Pacemaker Generator Function  
870.3640 Indirect pacemaker generator function analyzer. II  
  KRE -  Analyzer, Pacemaker Generator Function, Indirect  
870.3720 Pacemaker electrode function tester. II  
  DTA -  Tester, Pacemaker Electrode Function  
870.4075 Endomyocardial biopsy device. II  
  DWZ -  Device, Biopsy, Endomyocardial  
870.4205 Cardiopulmonary bypass bubble detector. II  
  KRL -  Detector, Bubble, Cardiopulmonary Bypass  
870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing. II  
  DWF -  Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass  
  NCP -  Cannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection  
870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter. II  
  JOD -  Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass  
870.4310 Cardiopulmonary bypass coronary pressure gauge. II  
  DXS -  Gauge, Pressure, Coronary, Cardiopulmonary Bypass  
870.4330 Cardiopulmonary bypass on-line blood gas monitor. II  
  DRY -  Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass  
870.4390 Cardiopulmonary bypass pump tubing. II  
  DWE -  Tubing, Pump, Cardiopulmonary Bypass  
870.4400 Cardiopulmonary bypass blood reservoir. II  
  DTN -  Reservoir, Blood, Cardiopulmonary Bypass  
  MJJ -  Cpb Check Valve, Retrograde Flow, In-Line  
870.4410 Cardiopulmonary bypass in-line blood gas sensor. II  
  DTY -  Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass  
870.4450 Vascular clamp. II  
  DXC -  Clamp, Vascular  
  MJN -  Catheter, Intravascular Occluding, Temporary  
  NMF -  Clamp, Vascular, Reprocessed  
870.4475 Surgical vessel dilator. II  
  DWP -  Dilator, Vessel, Surgical  
870.4500 Cardiovascular surgical instruments. I  
  NQG -  Stabilizer, Heart, Non-Compression, Reprocessed  
870.4875 Intraluminal artery stripper. II  
  DWX -  Stripper, Artery, Intraluminal  
  MCW -  Catheter, Peripheral, Atherectomy  
870.4885 External vein stripper. II  
  DWQ -  Stripper, Vein, External  
  MGZ -  Valvulotome  
870.5050 Patient care suction apparatus. II  
  DWM -  Apparatus, Suction, Patient Care  
870.5150 Embolectomy catheter. II  
  DXE -  Catheter, Embolectomy  
  MMX -  Device, Percutaneous Retrieval  
870.5175 Septostomy catheter. II  
  DXF -  Catheter, Septostomy  
870.5325 Defibrillator tester. II  
  DRL -  Tester, Defibrillator  
870.5800 Compressible limb sleeve. II  
  JOW -  Sleeve, Limb, Compressible  
  PPS -  Sleeve, Head And Neck, Compressible  
870.5900 Thermal regulating system. II  
  DWJ -  System, Thermal Regulating  
  NZE -  Hyperthermia Monitor  
870.5910 Esophageal thermal regulation device. II  
  PLA -  Esophageal Thermal Regulation And Gastric Suctioning Device  
870.5925 Automatic rotating tourniquet. II  
  DRP -  Tourniquet, Automatic Rotating  

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