# K201114: Bidop 7

- Pathway: 510(k) (Traditional)
- Applicant: Koven Technology, Inc.
- Decided: Jan 5, 2021 after 253 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: 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 4.

## Indications for use
The Bidop 7 is intended for the detection of arterial and venous blood flow in the extremities as well as fetal heart sounds. The Bidop 7 displays bi-directional velocity waveforms, numerical data and fetal heart rate with heartbeat indicator. The Bidop 7 probe selection is 2, 5, 8, and 10 MHz.

Source page: https://510kreport.com/device/K201114
Methodology: https://510kreport.com/methodology