Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sutures , Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
153 daysmedian FDA review time
182 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990432 | SURGISORB | Sutures , Ltd. | 1999-05-27 | 105 | 0 |
| K953609 | PRODEK | Sutures , Ltd. | 1996-01-31 | 182 | 0 |
| K943216 | SURGIDEK | Sutures , Ltd. | 1994-12-05 | 153 | 0 |
| K943223 | SURGIDEK B | Sutures , Ltd. | 1994-12-05 | 153 | 0 |
| K943222 | SURGIDEK S | Sutures , Ltd. | 1994-12-05 | 153 | 0 |
| K943221 | SURGIBOND | Sutures , Ltd. | 1994-12-05 | 153 | 0 |
| K943220 | SUTULENE | Sutures , Ltd. | 1994-12-05 | 153 | 0 |
| K943627 | SURGISILK | Sutures , Ltd. | 1994-12-05 | 132 | 0 |
| K943217 | PLAIN CATGUT | Sutures , Ltd. | 1994-12-05 | 153 | 0 |
| K943218 | CHROMIC CATGUT | Sutures , Ltd. | 1994-12-05 | 153 | 0 |
| K865038 | SURGISTEEL | Sutures , Ltd. | 1987-06-30 | 188 | 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