# K090510: Doppler Fetal Heartbeat Rate Detector

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Bestman Instrument Co., Ltd.
- Decided: Apr 29, 2010 after 427 days
- Product code: KNG (Monitor, Ultrasonic, Fetal)
- Device class: 2
- Regulation: 21 CFR 884.2660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930200 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040480: Sonotrax Ultrasonic Pocket Doppler, Edan Instruments, Inc. (2004) Summary page 2.

## Most influential descendants
- K242846: Doppler FHR Detector (BF-500D+, BF-560) (2025), 0 descendants of its own

## Indications for use
This Doppler can be used for the detection of average fetal heartbeat rate.

Source page: https://510kreport.com/device/K090510
Methodology: https://510kreport.com/methodology