Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgistar, Inc. — 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) |
|---|---|---|---|---|---|
| K030891 | SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK | Surgistar, Inc. | 2003-06-17 | 88 | 0 |
| K992978 | RICROKERATOME BLADE | Surgistar, Inc. | 1999-11-16 | 74 | 0 |
| K941747 | SURGISTAR TROCARS | Surgistar, Inc. | 1994-07-01 | 84 | 0 |
| K923689 | SURGISTAR BLADES | Surgistar, Inc. | 1992-09-09 | 47 | 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