Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MVR — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
61 daysmedian FDA review time
196 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190499 | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019-09-06 | 189 | 0 |
| K191252 | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019-07-09 | 61 | 1 |
| K143589 | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | 2015-01-16 | 29 | 0 |
| K142309 | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | 2014-09-16 | 28 | 0 |
| K132727 | GEM FLOW COUPLER DEVICE AND SYSTEM | Synovis Life Technologies, Inc. | 2013-10-22 | 49 | 1 |
| K093310 | GEM FLOW COUPLER DEVICE AND SYSTEM | Synovis Micro Companies Alliance, Inc. | 2010-02-01 | 102 | 0 |
| K090679 | VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM | Vioptix, Inc. | 2009-04-17 | 32 | 0 |
| K040163 | MICROVASCULAR ANASTOMOTIC DEVICE | Synovis Micro Companies Alliance, Inc. | 2004-04-16 | 81 | 1 |
| K861985 | 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) | 3M Company | 1986-12-04 | 196 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda