# K052190: Fetal Monitor, Models BT-300 and BT-200

- Pathway: 510(k) (Traditional)
- Applicant: Bistos Co., Ltd.
- Decided: Oct 4, 2005 after 54 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: 3 generations back to K930200 (1994). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 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.
- K040480: Sonotrax Ultrasonic Pocket Doppler, Edan Instruments, Inc. (2004) Summary page 1.

## Most influential descendants
- K100885: Fetal Monitor Model: BT-200T (2010), 1 descendant of its own
- K142799: Model BT-220L and BT-220C (2015), 0 descendants of its own
- K110630: F10 (2011), 0 descendants of its own

## Indications for use
The BT-300 Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer. The BT200 is a Fetal Monitor for measuring fetal heart rate. Data is displayed on a front panel LCD Display. Fetal heart rate may be measured by means of Doppler Ultrasound.

Source page: https://510kreport.com/device/K052190
Methodology: https://510kreport.com/methodology