510(k) · Cleared
ClearedGem 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 Sep 6, 2019 as substantially equivalent to K143589 (Synovis Life Technologies, Inc., 2015) after a 189-day review. Its family tree reaches back 4 generations to 2010.
- Decided
- Sep 6, 2019
- Review
- 189 days
- Class
- Class II
- Product code
- MVR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K093310 (2010). No later device cites it as a predicate yet.
- Root · 4 generations backK093310 Gem Flow Coupler Device and SystemSynovis Micro Companies Alliance, Inc. · 2010
- 3 generations backK132727 Gem Flow Coupler Device and SystemSynovis Life Technologies, Inc. · 2013 · Recalled
- 2 generations backK142309 GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc. · 2014
- 1 generation backK143589 GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc. · 2015 · Recalled
- This deviceK190499 Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K093310 | Gem Flow Coupler Device and System | Synovis Micro Companies Alliance, Inc. | 2010 | — |
| −3 | K132727 | Gem Flow Coupler Device and System | Synovis Life Technologies, Inc. | 2013 | 5 |
| −2 | K142309 | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | 2014 | — |
| −1 | K143589 | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | 2015 | 2 |
| 0 (this device) | K190499 | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019 | — |
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 |
|---|---|---|---|
| * | K143589 | GEM Flow COUPLER Device and SystemSummary page 4…f. Device Classification: Class II g. Classification Product Code: MVR and DPW h. Panel: General and Plastic Surgery III. PREDICATE DEVICE: K143589 GEM FlowCoupler System This predicate has not been subject to a design-related recall. PERFORMANCE STANDARDS… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K143589.
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 VESSEL EVERTER System is indicated for use with the Microvascular Anastomotic COUPLER and FLOW COUPLER Device in the anastomosis of only arteries normally encountered in microsurgical procedures only in the peripheral vascular system. The VESSEL EVERTER System is indicated for use with COUPLER and FLOW COUPLER System sizes from 2.0 to 4.0 mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190499 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190499: Gem FlowCoupler System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190499
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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