510(k) · Cleared
Recalled · Class II · 2016GEM Flow COUPLER Device and System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synovis Life Technologies, Inc. · MVR Device, Anastomotic, Microvascular
Cleared on Jan 16, 2015 as substantially equivalent to K142309 (Synovis Life Technologies, Inc., 2014) after a 29-day review. Its family tree reaches back 3 generations to 2010. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 16, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- MVR
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K093310 (2010). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK093310 Gem Flow Coupler Device and SystemSynovis Micro Companies Alliance, Inc. · 2010
- 2 generations backK132727 Gem Flow Coupler Device and SystemSynovis Life Technologies, Inc. · 2013 · Recalled
- 1 generation backK142309 GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc. · 2014
- This deviceK143589 GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK233394 Gem Flow Now (GEM2770-FN)Synovis Micro Companies Alliance · 2024
- Descendant · cites it directly · 0 of its ownK190499 Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K093310 | Gem Flow Coupler Device and System | Synovis Micro Companies Alliance, Inc. | 2010 | — |
| −2 | 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 | — |
| 0 (this device) | K143589 | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | 2015 | — |
| +1 | K233394 | Gem Flow Now (GEM2770-FN) | Synovis Micro Companies Alliance | 2024 | — |
| +1 | K190499 | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K142309 | GEM Flow COUPLER Device and System Our reading of the summary gave K142609, FDA’s number for CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (Guangzhou Wondfo Biotech Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GEM Flow COUPLER Device and System”. | 2014 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2016 | Class II | Z-1631-2016 | Package design/selection | Instructions for use booklet may puncture the outer Tyvek lid. |
| Apr 21, 2016 | Class II | Z-1630-2016 | Package design/selection | Instructions for use booklet may puncture the outer Tyvek lid. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K233394 (Synovis Micro Companies Alliance, 2024) has gone furthest, with 0 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. 2015, 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 (133 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143589 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143589: 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/K143589
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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