# K050601: Smartdop 45 Vascular Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Koven Technology, Inc.
- Decided: Apr 15, 2005 after 37 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954397 (1996). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K954397: Bidirectional Doppler W/Waveform Display, Koven Technology, Inc. (1996) Summary page 1.

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

## Indications for use
The Smartdop 45 detects arterial and venous blood flow in extremities as well as fetal heart sounds. The Smartdop 45 displays and prints bi-directional velocity waveform, numerical data and fetal heart rate with heart beat indicator. The Smartdop 45 probe selection is 2, 4, 5, 8 and 10 MHz.

Source page: https://510kreport.com/device/K050601
Methodology: https://510kreport.com/methodology