Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endooptiks, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
140 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083788 | ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR | Endooptiks, Inc. | 2009-03-03 | 74 | 0 |
| K042918 | MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 | Endooptiks, Inc. | 2004-11-22 | 31 | 0 |
| K003151 | MICROPOBE SERIES OF LASERS AND ACCESSORIES | Endooptiks, Inc. | 2001-01-08 | 90 | 0 |
| K945081 | TRANSTYMPANIC ENDOSCOPE | Endooptiks, Inc. | 1995-03-06 | 140 | 0 |
| K922917 | ENDOPROBES | Endooptiks, Inc. | 1992-09-28 | 103 | 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