• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

List of Devices for Third Party Review

  • Print
  • Share
  • E-mail
-

Database updated: February 7, 2002

See Related 

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.


Obstetrics/Gynecology

Help
Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
884.1050 Endocervical aspirator. II  
  HFC -  Aspirator, Endocervical   Pilot  
884.1060 Endometrial aspirator. II  
  HFF -  Aspirator, Endometrial   Pilot  
884.1100 Endometrial brush. II  
  HFE -  Brush, Endometrial   Pilot  
884.1175 Endometrial suction curette and accessories. II  
  HHK -  Curette, Suction, Endometrial (And Accessories)   Pilot  
884.1185 Endometrial washer. II  
  HFD -  Washer, Endometrial   Pilot  
884.1300 Uterotubal carbon dioxide insufflator and accessories. II  
  HES -  Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)   Pilot  
884.1560 Fetal blood sampler. II  
  HGW -  Sampler, Blood, Fetal   Pilot  
884.1630 Colposcope. II  
  HEX -  Colposcope (And Colpomicroscope)   Pilot  
  MOK -  Vaginoscope And Accessories   Pilot  
884.1660 Transcervical endoscope (amnioscope) and accessories. II  
  HEZ -  Endoscope, Transcervical (Amnioscope)(And Accessories)   Pilot  
  HGK -  Endoscope, Fetal Blood Sampling (And Accessories)   Pilot  
884.1690 Hysteroscope and accessories. II  
  HIH -  Hysteroscope (And Accessories)      
884.1700 Hysteroscopic insufflator. II  
  HIG -  Insufflator, Hysteroscopic      
884.1720 Gynecologic laparoscope and accessories. II  
PDF Guidance file for Gynecologic laparoscope and accessories. (21CFR884.1720)  
  HET -  Laparoscope, Gynecologic (And Accessories)      
884.1730 Laparoscopic insufflator. II  
  HIF -  Insufflator, Laparoscopic      
884.2225 Obstetric-gynecologic ultrasonic imager. II  
  HEM -  Imager, Ultrasonic Obstetric-Gynecologic      
  HEN -  Caliper, Fetal Head, Ultrasonic      
  HHJ -  Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic      
  HHX -  Holograph, Fetal, Acoustical      
884.2600 Fetal cardiac monitor. II  
  KXN -  Monitor, Cardiac, Fetal   Pilot  
884.2640 Fetal phonocardiographic monitor and accessories. II  
  HFP -  Monitor, Phonocardiographic, Fetal   Pilot  
884.2660 Fetal ultrasonic monitor and accessories. II  
  HEI -  Monitor, Heart-Valve Movement, Fetal, Ultrasonic      
  HEJ -  Monitor, Hemic Sound, Ultrasonic      
  HEK -  Monitor, Heart Sound, Fetal, Ultrasonic      
  HEL -  Monitor, Heart Rate, Fetal, Ultrasonic      
  HEP -  Monitor, Blood-Flow, Ultrasonic      
  HEQ -  Monitor, Pressure, Arterial, Fetal, Ultrasonic      
  KNG -  Monitor, Ultrasonic, Fetal      
  LXE -  Doppler, Fetal, Ultrasound      
  MAA -  Monitor, Fetal Doppler Ultrasound      
884.2675 Fetal scalp circular (spiral) electrode and applicator. II  
  HGP -  Electrode, Circular (Spiral), Scalp And Applicator   Pilot  
884.2700 Intrauterine pressure monitor and accessories. II  
  HFN -  Transducer, Pressure, Intrauterine   Pilot  
  HFO -  Recorder, Pressure, Intrauterine   Pilot  
  HGS -  Catheter, Intrauterine And Introducer   Pilot  
  KXO -  Monitor, Pressure, Intrauterine   Pilot  
884.2720 External uterine contraction monitor and accessories. II  
  HFM -  Monitor, Uterine Contraction, External (For Use In Clinic)   Pilot  
884.2740 Perinatal monitoring system and accessories. II  
  HGM -  System, Monitoring, Perinatal   Pilot  
884.2960 Obstetric ultrasonic transducer and accessories. II  
  HGL -  Transducer, Ultrasonic, Obstetric      
884.2980 Telethermographic system. I  
 General Guidance
  LHQ -  System, Telethermographic (Adjunctive Use)      
884.2982 Liquid crystal thermographic system. I  
 General Guidance
  KYA -  System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)      
  LHM -  System, Thermographic, Liquid Crystal      
884.3200 Cervical drain. II  
  HFL -  Drain, Cervical   Pilot  
884.3575 Vaginal pessary. II  
  HHW -  Pessary, Vaginal   Pilot  
884.3900 Vaginal stent. II  
  HDX -  Dilator, Vaginal   Pilot  
  HFK -  Mold, Vaginal   Pilot  
  KXP -  Stent, Vaginal   Pilot  
884.4120 Gynecologic electrocautery and accessories. II  
Guidance Withdrawn
  HGI -  Electrocautery, Gynecologic (And Accessories)      
884.4160 Unipolar endoscopic coagulator-cutter and accessories. II  
  HFG -  Coagulator, Laparoscopic, Unipolar (And Accessories)   Pilot  
  HFH -  Coagulator, Hysteroscopic (And Accessories)   Pilot  
  HFI -  Coagulator, Culdoscopic (And Accessories)   Pilot  
  KNF -  Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)   Pilot  
884.4260 Hygroscopic Laminaria cervical dilator. II  
  HDY -  Dilator, Cervical, Hygroscopic-Laminaria   Pilot  
884.4340 Fetal vacuum extractor. II  
  HDB -  Extractor, Vacuum, Fetal   Pilot  
884.4400 Obstetric forceps. II  
  HDA -  Forceps, Obstetrical   Pilot  
884.4500 Obstetric fetal destructive instrument. II  
  HDI -  Hook, Destructive, Obstetrical   Pilot  
  HFZ -  Craniotribe   Pilot  
  HGA -  Cranioclast   Pilot  
  HHN -  Cleidoclast   Pilot  
  KNB -  Instrument, Destructive, Fetal, Obstetric   Pilot  
884.4530 Obstetric-gynecologic specialized manual instrument. II  
  HCZ -  Forceps, Surgical, Gynecological   Pilot  
  HDC -  Tenaculum, Uterine   Pilot  
  HDP -  Elevator, Uterine   Pilot  
  HDZ -  Knife, Cervical Cone   Pilot  
  HFW -  Clamp, Umbilical   Pilot  
  HFX -  Clamp, Circumcision   Pilot  
  HHO -  Screw, Fibroid, Gynecological   Pilot  
  HHT -  Spatula, Cervical, Cytological   Pilot  
  HIB -  Speculum, Vaginal, Nonmetal   Pilot  
  HIC -  Speculum, Vaginal, Nonmetal, Fiberoptic   Pilot  
  LBX -  Pelvimeter, Internal   Pilot  
884.4550 Gynecologic surgical laser. II  
  HHR -  Laser, Surgical, Gynecologic      
  LLW -  Laser, Neodymium:Yag For Gynecologic Use      
884.4900 Obstetric table and accessories. II  
  HDD -  Table, Obstetrical, Ac-Powered (And Accessories)   Pilot  
  HEA -  Clip, Drape, Lithotomy   Pilot  
  HHP -  Table, Obstetrical, Manual (And Accessories)   Pilot  
  KNC -  Table, Obstetric (And Accessories)   Pilot  
884.5070 Vacuum abortion system. II  
  HGF -  Source, Abortion Unit, Vacuum   Pilot  
  HGG -  Controller, Abortion Unit, Vacuum   Pilot  
  HGH -  Cannula, Suction, Uterine   Pilot  
  HHI -  System, Abortion, Vacuum   Pilot  
884.5100 Obstetric anesthesia set. II  
  HEE -  Set, Anesthesia, Paracervical   Pilot  
  HEG -  Set, Anesthesia, Pudendal   Pilot  
  KNE -  Set, Anesthesia, Obstetric   Pilot  
884.5160 Powered breast pump. II  
  HGX -  Pump, Breast, Powered   Pilot  
884.5250 Cervical cap. II  
  HDR -  Cap, Cervical   Pilot  
884.5300 Condom. II  
Guidance Withdrawn
  HIS -  Condom      
  MOL -  Condom, Synthetic      
884.5310 Condom with spermicidal lubricant. II  
Guidance Withdrawn
  LTZ -  Condom With Nonoxynol-9      
884.5350 Contraceptive diaphragm and accessories. II  
  HDW -  Diaphragm, Contraceptive (And Accessories)   Pilot  
884.5390 Perineal heater. II  
  HGZ -  Heater, Perineal, Direct Contact   Pilot  
  HHA -  Heater, Perineal, Radiant, Non-Contact   Pilot  
  KND -  Heater, Perineal   Pilot  
884.5400 Menstrual cup. II  
  HHE -  Cup, Menstrual   Pilot  
884.5425 Scented or scented deodorized menstrual pad. II  
  HHL -  Pad, Menstrual, Scented   Pilot  
884.5460 Scented or scented deodorized menstrual tampon. II  
  HIL -  Tampon, Menstrual, Scented, Deodorized      
884.5470 Unscented menstrual tampon. II  
  HEB -  Tampon, Menstrual, Unscented      
884.5960 Genital vibrator for therapeutic use. II  
  KXQ -  Vibrator For Therapeutic Use, Genital   Pilot  
884.6100 Assisted reproduction needles. II  
Guidance Withdrawn
  MQE -  Needle, Assisted Reproduction      
884.6110 Assisted reproduction catheters. II  
Guidance Withdrawn
  MQF -  Catheter, Assisted Reproduction      
884.6120 Assisted reproduction accessories. II  
Guidance Withdrawn
  MQG -  Accessory, Assisted Reproduction      
884.6130 Assisted reproduction microtools. II  
Guidance Withdrawn
  MQH -  Microtools, Assisted Reproduction (Pipettes)      
884.6140 Assisted reproduction micropipette fabrication instruments. II  
Guidance Withdrawn
  MQI -  Microtool Fabrication, Assisted Reproduction      
884.6150 Assisted reproduction micromanipulators and microinjectors. II  
Guidance Withdrawn
  MQJ -  Micromanipulators And Microinjectors, Assisted Reproduction      
884.6160 Assisted reproduction labware. II  
Guidance Withdrawn
  MQK -  Labware, Assisted Reproduction      
884.6170 Assisted reproduction water and water purification systems. II  
 
  MTW -  System,Water,Reproduction,Assisted,And Purification      
884.6180 Reproductive media and supplements. II  
Guidance Withdrawn
  MQL -  Media, Reproductive      
884.6190 Assisted reproductive microscopes and microscope accessories. I  
 General Guidance
  MTX -  Microscope And Microscope Accessories,Reproduction,Assisted      

-
-