# K142769: Fetal Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Icare Newlife Technologies, Inc.
- Decided: Mar 20, 2015 after 176 days
- Product code: HEK (Monitor, Heart Sound, Fetal, Ultrasonic)
- 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: 5 generations back to K930200 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110124: Fetal Doppler JPD-100S, Shenzhen Jumper Medical Equipment Co., Ltd. (2011) Summary page 6.

## Indications for use
The iCareNewlife Fetal Doppler is indicated for monitoring fetal heart rate during the antepartum period as a general indication of fetal well-being. The device is for hearing fetal heart sounds through the speaker only. The device is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.

Source page: https://510kreport.com/device/K142769
Methodology: https://510kreport.com/methodology