Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Moria SA — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
281 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172994 | EPI K Console | Moria SA | 2017-10-26 | 29 | 0 |
| K043183 | EPI-K | Moria SA | 2005-03-25 | 128 | 0 |
| K032836 | M3 MICROKERATOME | Moria SA | 2004-06-18 | 281 | 0 |
| K040297 | ONEUSE- PLUS MICROKERATOME | Moria SA | 2004-03-31 | 51 | 0 |
| K022560 | M2 SINGLE USE MICROKERTOME | Moria SA | 2002-09-27 | 56 | 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