510(k) · Cleared
Recalled · Class II · 2023Gem FlowCoupler System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter/ Synovis Micro Companies Alliance, Inc. · MVR Device, Anastomotic, Microvascular
Cleared on Jul 9, 2019 as substantially equivalent to K093310 (Synovis Micro Companies Alliance, Inc., 2010) after a 61-day review. Its family tree reaches back 1 generation to 2010. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jul 9, 2019
- Review
- 61 days
- Class
- Class II
- Product code
- MVR
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093310 (2010). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK093310 Gem Flow Coupler Device and SystemSynovis Micro Companies Alliance, Inc. · 2010
- This deviceK191252 Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK213974 GEM FLOW COUPLER Monitor (GEM1020M-2)Synovis Micro Companies Alliance, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K213974GEM FLOW COUPLER Monitor (GEM1020M-2)Synovis Micro Companies Alliance, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093310 | Gem Flow Coupler Device and System | Synovis Micro Companies Alliance, Inc. | 2010 | — |
| 0 (this device) | K191252 | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019 | — |
| +1 | K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2) | Synovis Micro Companies Alliance, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MVR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093310 | Gem Flow Coupler Device and SystemSummary page 4…Classification: Class II Product Code MVR, DPW III. Predicate Device Predicate Device GEM FLOW COUPLER Device and System; K093310 (includes GEM FLOW COUPLER Monitor - GEM1020M) IV. Device Description The FLOW COUPLER Devi… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2) | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 19, 2023 | Class II | Z-2208-2023 | Under Investigation by firm | 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 last active channel prior to powering… |
| Dec 28, 2020 | Class II | Z-0939-2021 | Software design | Potential for the battery to lose its ability to be recharged. |
| Jun 2, 2020 | Class II | Z-2474-2020 | Device Design | A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MVR devicesMVR Device, Anastomotic, Microvascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MVR
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · MVR
Too few MVR 510(k)s in any year since 2007 to give a median.
Recalls per year · MVR
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVR
91in 2025
MAUDE reports naming product code MVR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 1 | 12 |
| 2009 | 1 | — | 0 | 23 |
| 2010 | 1 | — | 0 | 31 |
| 2011 | 0 | — | 0 | 28 |
| 2012 | 0 | — | 0 | 29 |
| 2013 | 1 | — | 0 | 21 |
| 2014 | 1 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 40 |
| 2016 | 0 | — | 0 | 22 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 0 | — | 1 | 43 |
| 2021 | 0 | — | 0 | 35 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 0 | — | 0 | 38 |
| 2025 | 0 | — | 0 | 91 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (134 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191252 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191252: Gem FlowCoupler System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191252
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026