# K233394: Gem Flow Now (GEM2770-FN)

- Pathway: 510(k) (Traditional)
- Applicant: Synovis Micro Companies Alliance
- Decided: Jan 28, 2024 after 117 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K093310 (2010). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143589: GEM Flow COUPLER Device and System, Synovis Life Technologies, Inc. (2015) Summary page 4.

## Indications for use
FLOW NOW is indicated for monitoring blood flow in peripheral vessels during and following reconstructive microvascular procedures, re-implantation, and free flap transfers. Postoperatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW NOW Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days postoperatively.

Source page: https://510kreport.com/device/K233394
Methodology: https://510kreport.com/methodology