Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgimetrics International, Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
321 daysmedian FDA review time
537 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931914 | SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE | Surgimetrics International, Ltd. | 1994-10-05 | 537 | 0 |
| K931917 | SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE | Surgimetrics International, Ltd. | 1994-03-03 | 321 | 0 |
| K931916 | SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER | Surgimetrics International, Ltd. | 1994-03-03 | 321 | 0 |
| K931918 | CATGUT SUTURE PLAIN | Surgimetrics International, Ltd. | 1994-03-03 | 321 | 0 |
| K931919 | CATGUT SUTURE CHROMIC | Surgimetrics International, Ltd. | 1994-03-03 | 321 | 0 |
| K931913 | SUTURE NON-ABSORBABLE SILK | Surgimetrics International, Ltd. | 1994-03-03 | 321 | 0 |
| K931915 | STAINLESS STEEL SUTURE | Surgimetrics International, Ltd. | 1994-03-03 | 321 | 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