Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ikonos Corp. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971252 | SEVRAIN CRANIAL CLAMP | Ikonos Corp. | 1998-07-06 | 459 | 0 |
| K971408 | SEVRAIN CRANIAL CLAMP (SCC-200 SERIES) | Ikonos Corp. | 1998-05-12 | 391 | 0 |
| K971454 | TYMPANOSTOMY VENTILATION TUBE | Ikonos Corp. | 1997-05-29 | 38 | 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