# K100626: Doppler Fetal Heart Rate Detector, Model FM-200

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Biocare Electronics Co., Ltd.
- Decided: May 21, 2010 after 77 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). 4 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082480: Contec Pocket Fetal  Doppler, Contec Medical System Co., Ltd. (2009) Summary page 1.

## Most influential descendants
- K112911: Fetal Doppler (2011), 8 descendants of its own
- K131457: Fetal Ultrasonic Monitor and Accessories (2014), 6 descendants of its own
- K182526: Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) (2019), 4 descendants of its own
- K220245: Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (2022), 1 descendant of its own
- K211940: Fetal Doppler (2022), 1 descendant of its own

## Indications for use
FM-200 Doppler Fetal Heart Rate Detector is a hand-held, battery powered Doppler devices used for detecting fetal heart beats.

Source page: https://510kreport.com/device/K100626
Methodology: https://510kreport.com/methodology