# K182526: Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)

- Pathway: 510(k) (Traditional)
- Applicant: Vcomin Technology Limited
- Decided: May 29, 2019 after 260 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: 7 generations back to K930200 (1994). 7 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131457: Fetal Ultrasonic Monitor and Accessories, Shenzhen Jumper Medical Equipment Co., Ltd. (2014) Summary page 4.

## Most influential descendants
- K220245: Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (2022), 1 descendant of its own
- K211940: Fetal Doppler (2022), 1 descendant of its own
- K252669: Fetal Doppler U8-25, U9-25 (2026), 0 descendants of its own
- K232893: Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) (2024), 0 descendants of its own

## Indications for use
The device 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.

Source page: https://510kreport.com/device/K182526
Methodology: https://510kreport.com/methodology