510(k) · Cleared
Recalled · 2008Microvascular Anastomotic Device
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 Apr 16, 2004 as substantially equivalent to K861985 (3M Company, 1986) after an 81-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 16, 2004
- Review
- 81 days
- Class
- Class II
- Product code
- MVR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K861985 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK861985 3M Brand Microvascular Anastomotic Coupler (27XX)3M Company · 1986 · Recalled
- This deviceK040163 Microvascular Anastomotic DeviceSynovis Micro Companies Alliance, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK090679 Vesselink Microvascular Anastomotic Coupler SystemVioptix, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K090679Vesselink Microvascular Anastomotic Coupler SystemVioptix, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861985 | 3M Brand Microvascular Anastomotic Coupler (27XX) | 3M Company | 1986 | 3 |
| 0 (this device) | K040163 | Microvascular Anastomotic Device | Synovis Micro Companies Alliance, Inc. | 2004 | — |
| +1 | K090679 | Vesselink Microvascular Anastomotic Coupler System | Vioptix, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K861985 | 3M Brand Microvascular Anastomotic Coupler (27XX)Summary page 4…11 (Fax) Device Trade Name: To be determined Common Name: Microvascular Anstornotic Coupler Predicate Device: '~,Microvascular Anastomotic COUPLER; K861 985 Device Description: The device is a sterile (gamma irradiation), single-use, implantable pair of ring… | 1986 |
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 |
|---|---|---|---|
| K090679 | Vesselink Microvascular Anastomotic Coupler System | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 14, 2008 | Not classified | Z-2138-2008 | Device Design | Coupler rings may slip out of the delivery toolcaused by jaws larger than specification. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K090679 (Vioptix, Inc., 2009) 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.
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 Microvascular Anastomotic COUPLER is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures.
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/K040163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040163: Microvascular Anastomotic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040163
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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