# K022649: Cook-Swartz Doppler Flow Probe

- Pathway: 510(k) (Special)
- Applicant: Cook Vascular, Inc.
- Decided: Sep 6, 2002 after 28 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: 1 generation back to K964001 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964001: Swartz Doppler Flow Probe and Monitor System, Med Institute, Inc. (1998) Summary page 1.

## Most influential descendants
- K171272: Cook-Swartz Doppler Flow Probe (2018), 0 descendants of its own

## Indications for use
The COOK- Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free flap transfers. The COOK-Swartz Doppler Flow Probe is supplied sterile and intended for one time use

Source page: https://510kreport.com/device/K022649
Methodology: https://510kreport.com/methodology