Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LCC · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
218 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112952 | ILWAIT TIMER OCULOPRESSOR | Oryx Medical Pty, Ltd. | 2012-05-10 | 218 | 0 |
| K946194 | WEE BAG O'MERCURY | Microsurgical Technology, Inc. | 1995-02-27 | 69 | 0 |
| K852032 | OCULAR PRESSURE REDUCER (MCCANNEL) | Visitec Co. | 1985-08-12 | 95 | 0 |
| K840004 | WEE BAG O'MERCURY | Surgi-Quip Inc.U | 1984-03-22 | 78 | 0 |
| K820526 | RELIEF VALVE-HONAN INTRAOC. PRESSURE | The Lebanon Corp. | 1982-03-25 | 27 | 0 |
| K792255 | NEVYAS AUTOPRESS EYE COMPRESSOR | Keeler Optical Products , Ltd. | 1979-12-11 | 32 | 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