Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cortek Endoscopy, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
83 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000199 | CORTEK MINI LAPAROSCOPE | Cortek Endoscopy, Inc. | 2000-04-13 | 83 | 0 |
| K000198 | CORTEK ARTHROSCOPE | Cortek Endoscopy, Inc. | 2000-04-11 | 81 | 0 |
| K000202 | CORTEK LAPAROSCOPES | Cortek Endoscopy, Inc. | 2000-03-31 | 70 | 0 |
| K000197 | CORTEK CYSTOSCOPE | Cortek Endoscopy, Inc. | 2000-03-03 | 42 | 0 |
| K000200 | CORTEK URETHEROSCOPE | Cortek Endoscopy, Inc. | 2000-03-03 | 42 | 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