# K031358: Transvaginal Doppler Probe

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Control Systems, Inc.
- Decided: May 9, 2003 after 9 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
Longest line of descent: 2 generations back to K935994 (1995). 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)
- K023024: Transvaginal Doppler Probe, Model 09-0006-02, Vascular Control Systems, Inc. (2002)

## Indications for use
The Transvaginal Doppler Probe is intended for bilateral detection of uterine blood vessels.

Source page: https://510kreport.com/device/K031358
Methodology: https://510kreport.com/methodology