Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Koros USA, 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) |
|---|---|---|---|---|---|
| K120590 | DILATOR TUBE SET | Koros USA, Inc. | 2013-05-07 | 434 | 0 |
| K101609 | SELF RETAINING SOFT TISSUE RETRACTOR | Koros USA, Inc. | 2010-12-09 | 184 | 0 |
| K082399 | PECTUS STRUT | Koros USA, Inc. | 2009-11-05 | 442 | 0 |
| K071338 | FLEX ARM RETRACTOR SYSTEM | Koros USA, Inc. | 2007-05-29 | 15 | 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