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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 PRESSUE 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 CONTINOUS 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 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 SIGNAL 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 PHETHYSMOGRAPH 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, AND 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 REGULATION SYSTEM II  
  DWJ -  System, Thermal Regulating   Pilot  
870.5925 AUTOMATIC ROTATING TOURNIQUET II  
  DRP -  Tourniquet, Automatic Rotating   Pilot  

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