# K100885: Fetal Monitor Model: BT-200T

- Pathway: 510(k) (Traditional)
- Applicant: Bistos Co., Ltd.
- Decided: Jun 7, 2010 after 69 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: 4 generations back to K930200 (1994). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052190: Fetal Monitor, Models BT-300 and BT-200, Bistos Co., Ltd. (2005) Summary page 3.

## Most influential descendants
- K142799: Model BT-220L and BT-220C (2015), 0 descendants of its own

## Indications for use
The BT-200T is a Fetal Monitor for measuring Fetal Heart Rate, Data is displayed on a front panel LCD display, Fetal heart may be measured by means of Doppler ultrasound.

Source page: https://510kreport.com/device/K100885
Methodology: https://510kreport.com/methodology