# K013547: Babycom

- Pathway: 510(k) (Traditional)
- Applicant: Pmg Medica, Ltd.
- Decided: Feb 20, 2002 after 119 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: 1 generation back to K930200 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930200: Multi Dopplex II / Fetal Dopplex II, Huntleigh Healthcare, Inc. (1994) Summary page 1.

## Indications for use
The Babycom™ is meant to be applied to a woman's abdomen during pregnancy in order to measure the fetal heart rate (FHR) as a general indicator of fetal well-being.

Source page: https://510kreport.com/device/K013547
Methodology: https://510kreport.com/methodology