# K142799: Model BT-220L and BT-220C

- Pathway: 510(k) (Traditional)
- Applicant: Bistos Co., Ltd.
- Decided: Jul 9, 2015 after 283 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930200 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100885: Fetal Monitor Model: BT-200T, Bistos Co., Ltd. (2010) Summary page 5.

## Indications for use
BT-220L/220C is a pocket sized ultrasonic fetal monitor that measures heart rate, which is displayed on an LCD display, and outputs fetal heart sounds through a built in speaker. The fetal heart rate is measured using Doppler ultrasound.

Source page: https://510kreport.com/device/K142799
Methodology: https://510kreport.com/methodology