Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
OCU · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
215 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202838 | Andorate Universal Endoscope Tip Guard | Ga Health Company Limited | 2021-03-05 | 161 | 0 |
| K191715 | Endoscope Tip Protector - Sterile, Endoscope Tip Protector - | STERIS Corporation | 2020-01-27 | 215 | 0 |
| K191011 | Scope ProTech | Meditech Endoscopy, Ltd. | 2019-05-07 | 21 | 0 |
| K030684 | SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH | Acmi Corporation | 2003-06-03 | 90 | 0 |
| K951104 | ENDOBOOT | United States Endoscopy Group, Inc. | 1995-04-06 | 27 | 0 |
| K940780 | SCOPEJOCKEY | Fibertech Instruments, Inc. | 1994-05-10 | 77 | 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