# K103545: BT-350

- Pathway: 510(k) (Traditional)
- Applicant: Bistos Co., Ltd.
- Decided: May 13, 2011 after 162 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: 2 generations back to K934959 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994008: Biosys Fetal Monitor, Model Ifm-500, Biosys Co., Ltd. (2000) Summary page 1.

## Indications for use
The BT-350 is a Prenatal Monitoring System for non-invasively measuring and showing graphically maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display and on a strip chart recorder. This data is intended to aid in assessing the well being of the fetus during the antepartum periods (Non-Stress Test). Therefore the BT-350 is not used in delivery room. This device is for use only by trained medical personnel located in hospitals, clinics, doctor's offices and in the patient's home.

Source page: https://510kreport.com/device/K103545
Methodology: https://510kreport.com/methodology