List of Devices for Third Party Review under the FDA Modernization Act of 1997

List of Devices for Third Party Review under the FDA Modernization Act of 1997
Database updated: February 7, 2002

This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program. In January 2001, FDA updated this list to include Class II devices that are part of the "expansion pilot," discussed below. 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ThirdPartyInspection/ucm125410.htm.

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.

You should contact FDA's Division of Small Manufacturers Assistance at dsma@cdrh.fda.gov or an Accredited Person if you need additional information on these exceptions.

Expansion Pilot

In an effort to encourage greater use of the Accredited Persons Program, FDA implemented an expansion pilot in January 2001 that allows Accredited Persons to review many Class II devices that were not previously eligible. The 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 a January 2001 guidance document entitled Guidance for Staff, Industry and Third Parties: Implementation of Third Party Programs Under the FDA Modernization Act of 1997. This guidance is a revision of the October 30, 1998 guidance document with the same title. 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.

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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     DRW -  Adaptor, Lead Switching, Electrocardiograph       870.2360 ELECTROCARDIOGRAPH ELECTRODE II     DRX -  Electrode, Electrocardiograph         MLN -  Electrode, Electrodcardiograph, Multi-Function   Pilot   870.2370 ELECTROCARDIOGRAPH SURFACE ELECTRODE TESTER II     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