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Doppler Fetal Heartbeat Rate Detector

by Shenzhen Bestman Instrument Co., Ltd. China 510(k)

510(k) K090510 Product code KNG

Overview

The Doppler Fetal Heartbeat Rate Detector is a Class II medical device classified under the nomenclature for Ultrasonic, Fetal Monitors (OpenFDA: KNG, regulation 884.2660). It employs ultrasound Doppler technology to non-invasively measure and display the fetal heart rate in pregnant women. This handheld device provides real-time monitoring of the fetal heartbeat, aiding in the assessment of fetal well-being during pregnancy and postpartum care. Its design aligns with obstetrics/gynecology applications, ensuring clinical utility in prenatal settings.

This device is supplied as a reusable instrument and is intended for use in clinical obstetrics settings. It operates without requiring MRI compatibility considerations and adheres to standard disinfection protocols. The device holds FDA 510K clearance (K090510) with a Substantially Equivalent determination by the Obstetrics/Gynecology Advisory Committee. Multiple registration numbers (e.g., 3030151584) reflect its compliance with U.S. regulatory requirements for fetal monitoring devices.

Doppler Fetal Heartbeat Rate Detector

Summary written by AI from registry data, 1 Oct 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK090510 Date29 Apr 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
KNG
Device Class
Class II
Regulation
21 CFR Part 884.2660
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Other devices from Shenzhen Bestman Instrument Co., Ltd.

Questions

  • What is the Doppler Fetal Heartbeat Rate Detector used for?

    The Doppler Fetal Heartbeat Rate Detector uses ultrasound Doppler technology to non-invasively measure and display the fetal heart rate in pregnant women. It provides real-time monitoring to assess fetal well-being during pregnancy and postpartum care, making it a key tool in obstetrics and gynecology settings.

  • Is the Doppler Fetal Heartbeat Rate Detector single-use or reusable?

    This device is designed as a reusable instrument. It is intended for clinical obstetrics settings and adheres to standard disinfection protocols to ensure safe reuse across multiple patients.

  • Does the Doppler Fetal Heartbeat Rate Detector require MRI compatibility?

    No, the Doppler Fetal Heartbeat Rate Detector does not require MRI compatibility considerations. Its design and materials are not intended for use in MRI environments.

  • What regulatory clearance does the Doppler Fetal Heartbeat Rate Detector hold?

    The device holds FDA 510K clearance (K090510) with a Substantially Equivalent determination by the Obstetrics/Gynecology Advisory Committee. This clearance reflects its compliance with U.S. regulatory requirements for fetal monitoring devices.

  • How is the Doppler Fetal Heartbeat Rate Detector supplied and stored?

    The device is supplied as a reusable instrument for clinical obstetrics settings. Proper storage involves maintaining cleanliness and adhering to standard disinfection protocols to ensure functionality and safety for repeated use.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K090510 24 fields · synced 22 Oct 2026