510(k) · Cleared
ClearedGem Flow Coupler Device and System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synovis Micro Companies Alliance, Inc. · MVR Device, Anastomotic, Microvascular
Cleared on Feb 1, 2010 after a 102-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Feb 1, 2010
- Review
- 102 days
- Class
- Class II
- Product code
- MVR
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK093310 Gem Flow Coupler Device and SystemSynovis Micro Companies Alliance, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK132727 Gem Flow Coupler Device and SystemSynovis Life Technologies, Inc. · 2013 · Recalled
- Descendant · cites it directly · 3 of its ownK142309 GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK143589 GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc. · 2015 · Recalled
- Descendant · cites it directly · 1 of its ownK191252 Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK233394 Gem Flow Now (GEM2770-FN)Synovis Micro Companies Alliance · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K132727Gem Flow Coupler Device and SystemSynovis Life Technologies, Inc. · 2013 · cites it directly4descendants
- K142309GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc. · 2014 · cites it directly3descendants
- K143589GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc. · 2015 · 2 generations on2descendants
- K191252Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc. · 2019 · cites it directly1descendant
- K233394Gem Flow Now (GEM2770-FN)Synovis Micro Companies Alliance · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093310 | Gem Flow Coupler Device and System | Synovis Micro Companies Alliance, Inc. | 2010 | — |
| +1 | K132727 | Gem Flow Coupler Device and System | Synovis Life Technologies, Inc. | 2013 | 5 |
| +1 | K142309 | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | 2014 | — |
| +2 | K143589 | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | 2015 | 2 |
| +1 | K191252 | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019 | 3 |
| +3 | K233394 | Gem Flow Now (GEM2770-FN) | Synovis Micro Companies Alliance | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K132727 (Synovis Life Technologies, Inc., 2013) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MVR devicesMVR Device, Anastomotic, Microvascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 | — |
https://510kreport.com/device/K093310 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093310: Gem Flow Coupler Device and System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093310
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026