510(k) · Cleared
ClearedVesselink Microvascular Anastomotic Coupler System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vioptix, Inc. · MVR Device, Anastomotic, Microvascular
Cleared on Apr 17, 2009 as substantially equivalent to K040163 (Synovis Micro Companies Alliance, Inc., 2004) after a 32-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Apr 17, 2009
- Review
- 32 days
- Class
- Class II
- Product code
- MVR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K861985 (1986). No later device cites it as a predicate yet.
- Root · 2 generations backK861985 3M Brand Microvascular Anastomotic Coupler (27XX)3M Company · 1986 · Recalled
- 1 generation backK040163 Microvascular Anastomotic DeviceSynovis Micro Companies Alliance, Inc. · 2004 · Recalled
- This deviceK090679 Vesselink Microvascular Anastomotic Coupler SystemVioptix, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K040163 | Microvascular Anastomotic DeviceSummary page 1…8.4300 The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Reference Device Name Applicant K040163 Microvascular Anastomotic Device Synovis Micro Companies Description of the device: The VesseLink Microvasc… | 2004 |
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 23 years and passes through 3 companies; a new generation was cleared every 17.4 years on median.
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All MVR devicesMVR Device, Anastomotic, Microvascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 VesseLink is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090679: Vesselink Microvascular Anastomotic Coupler System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090679
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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