Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OTZ — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
442 daysmedian FDA review time
683 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203586 | EndoSerter-PL | Corneagen, Inc. | 2022-02-02 | 421 | 0 |
| K121579 | EK DELIVERY DEVICE | Tdak Medical, Inc. | 2012-10-03 | 126 | 0 |
| K110734 | NCI SPATULA | Fischer Surgical, Inc. | 2012-05-31 | 442 | 0 |
| K102999 | TRIMOTION INJECTOR | Kaneka Corp. | 2011-12-29 | 447 | 0 |
| K090626 | ENDOSERTER | Ocular Systems, Inc. | 2011-01-21 | 683 | 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