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Fetal Doppler Model FD88

by Shenzzhen Luckcome Technology Inc., Ltd.

510(k) K182710

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182710 Date1 Mar 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
KNG
Device Class
Class II
Regulation
21 CFR Part 884.2660
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Fetal Doppler Model FD88 is a handheld, ultrasonic fetal monitoring device designed to detect and display fetal heart rate. Classified as a Monitor, Ultrasonic, Fetal, it employs Doppler ultrasound technology to provide real-time assessment of fetal cardiac activity, enabling clinicians to evaluate fetal well-being during pregnancy.

This device is intended for single-use or reusable applications in obstetric settings, supplied sterile or non-sterile as specified. It operates in non-MRI environments and is available in a portable form factor. Authorized under FDA 510(k) clearance (K182710) with a decision date of March 1, 2019, it adheres to regulatory requirements for Class II devices under product code KNG. Storage and usage follow manufacturer guidelines to maintain performance and accuracy.

Questions

AI-generated answers, 1 Oct 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 FD88 Fetal Doppler used for?

    The FD88 Fetal Doppler is designed to detect and display fetal heart rate in real-time using Doppler ultrasound technology. Clinicians use it to evaluate fetal cardiac activity and assess fetal well-being during pregnancy, particularly in obstetric settings.

  • How is the FD88 Fetal Doppler supplied, and can it be reused?

    The FD88 Fetal Doppler is available in both sterile and non-sterile configurations, allowing flexibility for single-use or reusable applications. The manufacturer specifies usage guidelines to ensure performance and accuracy, so proper cleaning and maintenance are required if reused.

  • Is the FD88 Fetal Doppler suitable for MRI environments?

    No, the FD88 Fetal Doppler is explicitly designed for use in non-MRI environments. Its materials and construction do not meet the safety requirements for MRI compatibility, so it should not be used in areas with magnetic resonance imaging equipment.

  • What regulatory approval does the FD88 Fetal Doppler hold?

    The FD88 Fetal Doppler holds FDA 510(k) clearance under the classification of a Class II medical device, with a decision date of March 1, 2019. It is substantially equivalent to predicate devices and adheres to regulatory requirements for obstetric/gynecological monitoring.

  • How should the FD88 Fetal Doppler be stored?

    Storage instructions for the FD88 Fetal Doppler follow manufacturer guidelines to maintain performance and accuracy. Proper storage conditions, including temperature and humidity control, should be adhered to, especially if the device is reusable or stored for extended periods.