# K191110: HeraBEAT™ US

- Pathway: 510(k) (Traditional)
- Applicant: Heramed, Ltd.
- Decided: Nov 14, 2019 after 202 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: 6 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)
- K112911: Fetal Doppler, Beijing Choice Electronic Technololgy Co., Ltd. (2011) Summary page 4.

## Indications for use
HeraBEAT™ US is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. HeraBEAT™ US is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.

Source page: https://510kreport.com/device/K191110
Methodology: https://510kreport.com/methodology