# K191252: Gem FlowCoupler System

- Pathway: 510(k) (Traditional)
- Applicant: Baxter/ Synovis Micro Companies Alliance, Inc.
- Decided: Jul 9, 2019 after 61 days
- Product code: MVR (Device, Anastomotic, Microvascular)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K093310 (2010). 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)
- K093310: Gem Flow Coupler Device and System, Synovis Micro Companies Alliance, Inc. (2010) Summary page 4.

## Most influential descendants
- K213974: GEM FLOW COUPLER Monitor (GEM1020M-2) (2022), 0 descendants of its own

## Recalls of this device
- Jun 19, 2023 · Class II · Z-2208-2023: An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the
- Dec 28, 2020 · Class II · Z-0939-2021: Potential for the battery to lose its ability to be recharged.
- Jun 2, 2020 · Class II · Z-2474-2020: A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.

## Indications for use
The FLOW COUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FLOW COUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FLOW COUPLER Device is used in conjunction with the FLOW COUPLER Monitor, the FLOW COUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW COUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post- operatively.

Source page: https://510kreport.com/device/K191252
Methodology: https://510kreport.com/methodology