# K110630: F10

- Pathway: 510(k) (Traditional)
- Applicant: Mediana Co., Ltd.
- Decided: Jun 24, 2011 after 113 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: 4 generations back to K930200 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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.
- K052190: Fetal Monitor, Models BT-300 and BT-200, Bistos Co., Ltd. (2005)

## Indications for use
The F10 Fetal Doppler measures heart rate, which is displayed on a LCD display and provides fetal heart sounds. The fetal heart rate is measured using Doppler ultrasound. Intended use : Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K110630
Methodology: https://510kreport.com/methodology