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Fetal Doppler

by Icare Newlife Technologies, Inc.

510(k) K142769

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142769 Date20 Mar 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Fetal Doppler is a Monitor, Heart Sound, Fetal, Ultrasonic device used for monitoring fetal heart rate during the antepartum period as a general indication of fetal well-being. It is intended to detect heart sounds through the speaker only.

The device is intended for use by health care professionals including registered nurses, midwives, ultrasound technicians, and physician assistants, by prescription. It received FDA 510(k) clearance under K142769 on March 20, 2015, and is classified as a Class II medical device under regulation number 884.2660.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Fetal Doppler used for?

    The Fetal Doppler is used to monitor fetal heart rate during the antepartum period as a general indication of fetal well-being by detecting heart sounds through the speaker only, intended for use by healthcare professionals under prescription.

  • Who is authorized to use the Fetal Doppler and how is it accessed?

    The device is intended for use by registered nurses, midwives, ultrasound technicians, and physician assistants, and requires a prescription for professional healthcare use.

  • What regulatory pathway and classification apply to the Fetal Doppler?

    The Fetal Doppler received FDA 510(k) clearance under K142769 on March 20, 2015, and is classified as a Class II medical device under regulation number 884.2660 in the Obstetrics/Gynecology specialty.