# K954397: Bidirectional Doppler W/Waveform Display

- Pathway: 510(k) (Traditional)
- Applicant: Koven Technology, Inc.
- Decided: Mar 29, 1996 after 191 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K050601: Smartdop 45 Vascular Doppler (2005), 2 descendants of its own
- K201114: Bidop 7 (2021), 0 descendants of its own
- K121267: BT-200V Vascular Doppler (2012), 0 descendants of its own

## Recalls of this device
- Mar 4, 2026 · Class II · Z-1631-2026: Product labeling includes a fetal indication for use that is not cleared under its 510(k).

Source page: https://510kreport.com/device/K954397
Methodology: https://510kreport.com/methodology