Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Synovis Life Technologies, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
195 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223052 | Peri-Guard and Supple Peri-Guard | Synovis Life Technologies, Inc. | 2023-04-07 | 190 | 4 |
| K221032 | Vascu-Guard Vascular Repair Patch | Synovis Life Technologies, Inc. | 2022-10-19 | 195 | 1 |
| K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | 2022-10-19 | 195 | 1 |
| K143589 | GEM Flow COUPLER Device and System | Synovis Life Technologies, Inc. | 2015-01-16 | 29 | 0 |
| K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | 2015-01-07 | 127 | 0 |
| K142461 | VASCU-GUARD Peripheral Vascular Patch | Synovis Life Technologies, Inc. | 2014-11-25 | 84 | 1 |
| 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 |
| K130896 | VASCULAR PROBE, VASCULAR PROBE ES | Synovis Life Technologies, Inc. | 2013-04-24 | 23 | 2 |
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