Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MMQ — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
155 daysmedian FDA review time
210 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981665 | SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE | Bio-Medical Sciences, Inc. | 1998-12-07 | 210 | 0 |
| K964702 | EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 | Euclid Systems Corp. | 1997-05-20 | 176 | 0 |
| K964891 | ORBSHOT KERATOMETER | Orbtek, Inc. | 1997-03-26 | 110 | 0 |
| K963762 | CORNEAL TOPOGRAPHER 200 | Eclipse Ventures | 1996-12-23 | 95 | 0 |
| K950077 | INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) | Par Vision Systems Corp. | 1995-06-14 | 155 | 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