Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sutura, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
89 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062125 | SUPERSTITCH 5F, 12F, AND EL | Sutura, Inc. | 2006-10-19 | 86 | 0 |
| K053482 | SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW | Sutura, Inc. | 2005-12-27 | 13 | 0 |
| K020940 | SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15 | Sutura, Inc. | 2002-04-17 | 26 | 0 |
| K012865 | SUPERSTITCH VASCULAR SUTURING DEVICE | Sutura, Inc. | 2001-09-25 | 29 | 0 |
| K994087 | SUPERSTITCH | Sutura, Inc. | 2000-03-01 | 89 | 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