# K121267: BT-200V Vascular Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Bistos Co., Ltd.
- Decided: Aug 2, 2012 after 98 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 K954397 (1996). 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)
- K050601: Smartdop 45 Vascular Doppler, Koven Technology, Inc. (2005) Summary page 1.

## Indications for use
The BT-200V Vascular Doppler ( Brand ui-dop) detects arterial and venous blood flow in extremities as well as fetal heart sounds. and displays velocity waveform, numerical data and fetal heart rate with heart beat indicator. The BT-200V selection is 2, 4, 5 and 8 M4Hz.

Source page: https://510kreport.com/device/K121267
Methodology: https://510kreport.com/methodology