# K935994: PW Doppler Vascular Probes

- Pathway: 510(k) (Traditional)
- Applicant: Koven Technology, Inc.
- Decided: May 11, 1995 after 512 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 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
- K023024: Transvaginal Doppler Probe, Model 09-0006-02 (2002), 2 descendants of its own
- K011863: VCS-a Series Clamp (2002), 2 descendants of its own
- K023154: VCS-a Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02 (2002), 1 descendant of its own
- K032125: Cstat, Models 09-0014-01 and 09-0014-02 (2004), 0 descendants of its own
- K031358: Transvaginal Doppler Probe (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K935994
Methodology: https://510kreport.com/methodology