Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Suturtek Incorporated — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082828 | SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE | Suturtek Incorporated | 2008-10-14 | 19 | 0 |
| K063603 | SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S1 | Suturtek Incorporated | 2007-02-07 | 66 | 0 |
| K032468 | SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE | Suturtek Incorporated | 2003-09-23 | 43 | 0 |
| K030227 | SUTURTEK FASTCLOSE SUTURING DEVICE | Suturtek Incorporated | 2003-03-17 | 54 | 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