# K182710: Fetal Doppler, Model FD88

- Pathway: 510(k) (Traditional)
- Applicant: Shenzzhen Luckcome Technology Inc., Ltd.
- Decided: Mar 1, 2019 after 155 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: 8 generations back to K930200 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180419: Ultrasonic Doppler (Model YM-2T8), Shenzhen Imdk Medical Technology Co., Ltd. (2018) Summary page 4.

## Indications for use
The Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound from early gestation. The device should only be used by a trained medical professional in a clinical setting and is not intended for operated by the patient at home.

Source page: https://510kreport.com/device/K182710
Methodology: https://510kreport.com/methodology