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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: February 7, 2002

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This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program. Premarket notifications ["510(k)'s"] for devices on this list can be submitted to FDA-accredited third parties (Accredited Persons) in lieu of FDA. Information on the Accredited Persons Program, including links to this page and to a list of Accredited Persons, is available at the Accredited Persons Inspection Program website.

The following topics are discussed in this introduction to the list of eligible devices:

  • How to use the list of eligible devices
  • Some important exceptions to the list
  • Expansion pilot

How to Use the List of Eligible Devices

The list has five 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 indicates if a device (product code) is included in the expansion pilot, described below, by showing the word "pilot." If this column is blank, the device is eligible for review under the pre-existing program and is not part of the expansion pilot.
  • The fifth column provides a link to device-specific guidance, if available, or to general guidance to assist manufacturers in the preparation-and Accredited Persons in the review-of 510(k)'s for eligible devices. Links are not provided for devices in the expansion pilot; device-specific guidance does not exist for these devices, and special procedures apply to the review of 510(k)'s for these devices by Accredited Persons, as discussed in FDA's January 2001 procedural guidance for the Accredited Persons Program, cited below.
Some Important Exceptions to the List

There are some exceptions that are not reflected in the eligible device list:

  • A device may be eligible even if it does not appear on the list if it is a Class I or Class II device that has been exempted from 510(k) by regulation, but requires a 510(k) because it exceeds the limitations of the exemption (as discussed in FDA's device classification regulations). Devices that are exempt from 510(k) are not shown on the list.
  • A Class II device on the list is ineligible if a 510(k) for the device requires clinical data to demonstrate substantial equivalence. This exception is discussed in FDA's procedural guidance for the Accredited Persons Program, cited below.
  • A device on the list is ineligible if a 510(k) for the device requires multi-Center review (e.g., 510(k)'s for drug/device combination products) or if a Center other than CDRH (e.g., the Center for Biologics Evaluation and Research) has primary responsibility for review.
Expansion Pilot

In an effort to encourage greater use of the Accredited Persons Program, FDA expanded the third party pilot to permit Accredited Persons to review many Class II devices that were not previously eligible. The expanded pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. Information on the expansion pilot, including criteria allowing for the review of these Class II devices, can be found in the guidance document entitled Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties. Accredited Persons and other interested parties should refer to Section II.B., Purpose and Nature of the Program, for the criteria that would allow for the review of the Class II devices in the expansion pilot.


Cardiovascular

Help
Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
870.1100 Blood pressure alarm. II  
  DSJ -  Alarm, Blood-Pressure   Pilot  
870.1110 Blood pressure computer. II  
  DSK -  Computer, Blood-Pressure   Pilot  
870.1120 Blood pressure cuff. II  
  DXQ -  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   Pilot  
870.1200 Diagnostic intravascular catheter. II  
  DQO -  Catheter, Intravascular, Diagnostic   Pilot  
870.1210 Continuous flush catheter. II  
  KRA -  Catheter, Continuous Flush   Pilot  
870.1230 Fiberoptic oximeter catheter. II  
  DQE -  Catheter, Oximeter, Fiberoptic   Pilot  
870.1240 Flow-directed catheter. II  
  DYG -  Catheter, Flow Directed   Pilot  
870.1250 Percutaneous catheter. II  
  DQY -  Catheter, Percutaneous   Pilot  
  LIT -  Catheter, Angioplasty, Peripheral, Transluminal   Pilot  
870.1270 Intracavitary phonocatheter system. II  
  DXW -  System, Phonocatheter, Intracavitary   Pilot  
870.1280 Steerable catheter. II  
  DRA -  Catheter, Steerable   Pilot  
870.1290 Steerable catheter control system. II  
  DXX -  System, Catheter Control, Steerable   Pilot  
870.1300 Catheter cannula. II  
  DQR -  Cannula, Catheter   Pilot  
870.1310 Vessel dilator for percutaneous catheterization. II  
  DRE -  Dilator, Vessel, For Percutaneous Catheterization   Pilot  
870.1330 Catheter guide wire. II  
  DQX -  Wire, Guide, Catheter   Pilot  
  MOF -  Guide, Wire, Catheter, Neurovasculature   Pilot  
870.1340 Catheter introducer. II  
  DYB -  Introducer, Catheter   Pilot  
870.1370 Catheter tip occluder. II  
  DQT -  Occluder, Catheter Tip   Pilot  
870.1380 Catheter stylet. II  
  DRB -  Stylet, Catheter   Pilot  
870.1390 Trocar. II  
  DRC -  Trocar   Pilot  
870.1425 Programmable diagnostic computer. II  
  DQK -  Computer, Diagnostic, Programmable   Pilot  
870.1435 Single-function, preprogrammed diagnostic computer. II  
  DXG -  Computer, Diagnostic, Pre-Programmed, Single-Function   Pilot  
870.1450 Densitometer. II  
  DXM -  Densitometer   Pilot  
870.1650 Angiographic injector and syringe. II  
  DXT -  Injector And Syringe, Angiographic   Pilot  
  IZQ -  Injector, Contrast Medium, Automatic   Pilot  
  MAV -  Syringe, Balloon Inflation   Pilot  
870.1660 Indicator injector. II  
  DXL -  Injector, Indicator   Pilot  
870.1670 Syringe actuator for an injector. II  
  DQF -  Actuator, Syringe, Injector Type   Pilot  
870.1800 Withdrawal-infusion pump. II  
  DQI -  Withdrawal/Infusion Pump   Pilot  
870.1875 Stethoscope. II  
 
  OCR -  Lung Sound Monitor      
  DQD -  Stethoscope, Electronic   Pilot  
870.1915 Thermodilution probe. II  
  KRB -  Probe, Thermodilution   Pilot  
870.2050 Biopotential amplifier and signal conditioner. II  
  DRR -  Amplifier And Signal Conditioner, Biopotential   Pilot  
870.2060 Transducer signal amplifier and conditioner. II  
  DRQ -  Amplifier And Signal Conditioner, Transducer Signal   Pilot  
870.2100 Cardiovascular blood flowmeter. II  
  DPW -  Flowmeter, Blood, Cardiovascular   Pilot  
870.2120 Extravascular blood flow probe. II  
  DPT -  Probe, Blood-Flow, Extravascular   Pilot  
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)   Pilot  
870.2310 Apex cardiograph (vibrocardiograph). II  
  DQH -  Cardiograph, Apex (Vibrocardiograph)   Pilot  
870.2320 Ballistocardiograph. II  
  DXR -  Ballistocardiograph   Pilot  
870.2330 Echocardiograph. II  
  DXK -  Echocardiograph      
870.2340 Electrocardiograph. II  
  DPS -  Electrocardiograph      
  MLC -  Monitor, St Segment      
870.2350 Electrocardiograph lead switching adaptor. II  
  HTML Guidance file for Electrocardiograph lead switching adaptor. (21CFR870.2350)
  DRW -  Adaptor, Lead Switching, Electrocardiograph      
870.2360 Electrocardiograph electrode. II  
  HTML Guidance file for Electrocardiograph electrode. (21CFR870.2360)
PDF Guidance file for Electrocardiograph electrode. (21CFR870.2360)  
  DRX -  Electrode, Electrocardiograph      
  MLN -  Electrode, Electrodcardiograph, Multi-Function   Pilot  
870.2370 Electrocardiograph surface electrode tester. II  
  HTML Guidance file for Electrocardiograph surface electrode tester. (21CFR870.2370)
  KRC -  Tester, Electrode, Surface, Electrocardiographic      
870.2400 Vectorcardiograph. II  
  DYC -  Vectorcardiograph   Pilot  
870.2450 Medical cathode-ray tube display. II  
  DXJ -  Display, Cathode-Ray Tube, Medical   Pilot  
870.2675 Oscillometer. II  
  DRZ -  Oscillometer   Pilot  
870.2750 Impedance phlebograph. II  
  DQB -  Phlebograph, Impedance   Pilot  
870.2770 Impedance plethysmograph. II  
 
  DSB -  Plethysmograph, Impedance   Pilot  
  MNW -  Analyzer, Body Composition   Pilot  
  OAC -  Plethysmograph, Air Displacement For Body Composition Analysis      
  OBH -  Monitor, Extracellular Fluid, Lymphedema, Extremity      
870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs. II  
  JOM -  Plethysmograph, Photoelectric, Pneumatic Or Hydraulic   Pilot  
870.2800 Medical magnetic tape recorder. II  
  DSH -  Recorder, Magnetic Tape, Medical   Pilot  
870.2840 Apex cardiographic transducer. II  
  JON -  Transducer, Apex Cardiographic   Pilot  
870.2850 Extravascular blood pressure transducer. II  
  DRS -  Transducer, Blood-Pressure, Extravascular   Pilot  
870.2860 Heart sound transducer. II  
  JOO -  Transducer, Heart Sound   Pilot  
870.2870 Catheter tip pressure transducer. II  
  DXO -  Transducer, Pressure, Catheter Tip   Pilot  
870.2880 Ultrasonic transducer. II  
  JOP -  Transducer, Ultrasonic      
870.2890 Vessel occlusion transducer. II  
  DXP -  Transducer, Vessel Occlusion   Pilot  
870.2900 Patient transducer and electrode cable (including connector). II  
  DSA -  Cable, Transducer And Electrode, Patient, (Including Connector)   Pilot  
870.2910 Radiofrequency physiological signal transmitter and receiver. II  
  DRG -  Transmitters And Receivers, Physiological Signal, Radiofrequency   Pilot  
870.2920 Telephone electrocardiograph transmitter and receiver. II  
  DXH -  Transmitters And Receivers, Electrocardiograph, Telephone   Pilot  
870.3630 Pacemaker generator function analyzer. II  
  DTC -  Analyzer, Pacemaker Generator Function   Pilot  
870.3640 Indirect pacemaker generator function analyzer. II  
  KRE -  Analyzer, Pacemaker Generator Function, Indirect   Pilot  
870.3720 Pacemaker electrode function tester. II  
  DTA -  Tester, Pacemaker Electrode Function   Pilot  
870.4075 Endomyocardial biopsy device. II  
  DWZ -  Device, Biopsy, Endomyocardial   Pilot  
870.4205 Cardiopulmonary bypass bubble detector. II  
  KRL -  Detector, Bubble, Cardiopulmonary Bypass   Pilot  
870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing. II  
  DWF -  Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass   Pilot  
  NCP -  Cannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection   Pilot  
870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter. II  
  JOD -  Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass   Pilot  
870.4280 Cardiopulmonary prebypass filter. II  
  KRJ -  Filter, Prebypass, Cardiopulmonary Bypass   Pilot  
870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. II  
  DTL -  Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass   Pilot  
870.4310 Cardiopulmonary bypass coronary pressure gauge. II  
  DXS -  Gauge, Pressure, Coronary, Cardiopulmonary Bypass   Pilot  
870.4330 Cardiopulmonary bypass on-line blood gas monitor. II  
  DRY -  Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass   Pilot  
870.4340 Cardiopulmonary bypass level sensing monitor and/or control. II  
  DTW -  Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass   Pilot  
870.4390 Cardiopulmonary bypass pump tubing. II  
  DWE -  Tubing, Pump, Cardiopulmonary Bypass   Pilot  
870.4400 Cardiopulmonary bypass blood reservoir. II  
  DTN -  Reservoir, Blood, Cardiopulmonary Bypass   Pilot  
  MJJ -  Cpb Check Valve, Retrograde Flow, In-Line   Pilot  
870.4410 Cardiopulmonary bypass in-line blood gas sensor. II  
  DTY -  Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass   Pilot  
870.4420 Cardiopulmonary bypass cardiotomy return sucker. II  
  DTS -  Sucker, Cardiotomy Return, Cardiopulmonary Bypass   Pilot  
870.4430 Cardiopulmonary bypass intracardiac suction control. II  
  DWD -  Suction Control, Intracardiac, Cardiopulmonary Bypass   Pilot  
870.4450 Vascular clamp. II  
  DXC -  Clamp, Vascular   Pilot  
  MJN -  Catheter, Intravascular Occluding, Temporary   Pilot  
  NMF -  Clamp, Vascular, Reprocessed   Pilot  
870.4475 Surgical vessel dilator. II  
  DWP -  Dilator, Vessel, Surgical   Pilot  
870.4875 Intraluminal artery stripper. II  
  DWX -  Stripper, Artery, Intraluminal   Pilot  
  MCW -  Catheter, Peripheral, Atherectomy   Pilot  
870.4885 External vein stripper. II  
  DWQ -  Stripper, Vein, External   Pilot  
  MGZ -  Valvulotome   Pilot  
870.5050 Patient care suction apparatus. II  
  DWM -  Apparatus, Suction, Patient Care   Pilot  
870.5150 Embolectomy catheter. II  
  DXE -  Catheter, Embolectomy   Pilot  
  MMX -  Device, Percutaneous Retrieval   Pilot  
870.5175 Septostomy catheter. II  
  DXF -  Catheter, Septostomy   Pilot  
870.5325 Defibrillator tester. II  
  DRL -  Tester, Defibrillator   Pilot  
870.5800 Compressible limb sleeve. II  
  JOW -  Sleeve, Limb, Compressible   Pilot  
870.5900 Thermal regulating system. II  
  DWJ -  System, Thermal Regulating   Pilot  
870.5925 Automatic rotating tourniquet. II  
  DRP -  Tourniquet, Automatic Rotating   Pilot  

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