# K031091: Vti 20 MHZ Gated Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Technology Incorporated
- Decided: Apr 23, 2003 after 16 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jun 19, 2018 · Class II · Z-3026-2018: Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver

## Indications for use
The VTI 20 MHz Gated Doppler is intended for the intraoperative and transcutaneous evaluation of blood flow.

Source page: https://510kreport.com/device/K031091
Methodology: https://510kreport.com/methodology