# K023082: Babycare

- Pathway: 510(k) (Abbreviated)
- Applicant: Bionet Company, Ltd.
- Decided: Mar 3, 2003 after 167 days
- Product code: HEP (Monitor, Blood-Flow, 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: 1 generation back to K910462 (1991). 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)
- K910462: Pocket Dop 3, Imex Medical Systems, Inc. (1991) Summary page 2.

## Indications for use
BABYCARE is a fetal ultrasonic monitor designed to transmit and receive ultrasonic energy into and from the pregnant woman by means of continuous wave (doppler) echoscopy. BABYCARE is a compact pocket Doppler, and it is intended for use to display the measured Fetal Heart Rate on LCD and to allow the user to hear a crystal clear Fetal Heart Beat Sound.

Source page: https://510kreport.com/device/K023082
Methodology: https://510kreport.com/methodology