Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Proxy Biomedical , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
241 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172636 | VitaMESH Macroporous PP Surgical Mesh | Proxy Biomedical , Ltd. | 2018-04-30 | 241 | 0 |
| K111121 | VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH | Proxy Biomedical , Ltd. | 2011-05-13 | 22 | 0 |
| K060520 | VITAMESH MACROPOROUS PP SURGICAL MESH | Proxy Biomedical , Ltd. | 2006-03-28 | 29 | 0 |
| K052100 | MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH | Proxy Biomedical , Ltd. | 2005-08-11 | 8 | 0 |
| K051245 | POLYFORM SYNTHETIC MESH | Proxy Biomedical , Ltd. | 2005-06-17 | 32 | 0 |
| K050678 | MOTIFMESH SOFT TISSUE PATCH | Proxy Biomedical , Ltd. | 2005-05-20 | 65 | 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