# K171272: Cook-Swartz Doppler Flow Probe

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jul 17, 2018 after 442 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 K964001 (1998). 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)
- K022649: Cook-Swartz Doppler Flow Probe, Cook Vascular, Inc. (2002) Summary page 5.

## Indications for use
The Cook-Swartz Doppler Flow Probe is 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 intended for use with the Swartz Doppler Monitoring System for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers.

Source page: https://510kreport.com/device/K171272
Methodology: https://510kreport.com/methodology