# K252669: Fetal Doppler U8-25, U9-25

- Pathway: 510(k) (Traditional)
- Applicant: Zhongshan Xiaolan Town Senlan Electronic Factory
- Decided: Jan 8, 2026 after 136 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: 9 generations back to K930200 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211940: Fetal Doppler, Shenzhen Taikang Medical Equipment Co., Ltd. (2022) Summary page 6.

## Indications for use
The Fetal Doppler is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. The device is intended for use at or after 16 weeks gestation.

Source page: https://510kreport.com/device/K252669
Methodology: https://510kreport.com/methodology