# K242846: Doppler FHR Detector (BF-500D+, BF-560)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Bestman Instrument Co., Ltd.
- Decided: Jun 26, 2025 after 279 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: 4 generations back to K930200 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090510: Doppler Fetal Heartbeat Rate Detector, Shenzhen Bestman Instrument Co., Ltd. (2010) Summary page 5.

## Indications for use
The Doppler FHR Detector (Model BF-500D+ and BF-560) is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound in patients with singleton pregnancies after 12 weeks of gestation. The device is intended to be used by health care professionals in a hospital, clinic, community, and home setting.

Source page: https://510kreport.com/device/K242846
Methodology: https://510kreport.com/methodology