# K082055: Model PC-860 Fetal Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Creative Industry Co., Ltd.
- Decided: Feb 6, 2009 after 200 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: 3 generations back to K930200 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040480: Sonotrax Ultrasonic Pocket Doppler, Edan Instruments, Inc. (2004) Summary page 1.

## Indications for use
The device is an ultrasonic fetal heart beat detector, which can detect the Fetal Heart Rate. The built in speaker of the device allows for listening of the fetal heartbeat.

Source page: https://510kreport.com/device/K082055
Methodology: https://510kreport.com/methodology