# K212084: Fetal Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mericonn Technology Co., Ltd.
- Decided: Nov 3, 2021 after 124 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153475: SD5 & SD6 Ultrasonic Tabletop Doppler, Edan Instruments, Inc. (2016) Summary page 4.

## Indications for use
Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. Fetal Doppler is indicated for use by health care professionals in hospital, clinic, community and home for singleton pregnancies after 12 weeks gestation.

Source page: https://510kreport.com/device/K212084
Methodology: https://510kreport.com/methodology