Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Moria, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003594 | CARRIAZO BARRAQUER SINGLE USE MICROKERATOME | Moria, Inc. | 2001-03-09 | 108 | 0 |
| K002191 | CARRIAZO BARRAQUER II MICROKERATOME | Moria, Inc. | 2000-10-12 | 84 | 0 |
| K981742 | ONE UP DISPOSABLE KERATOME HEAD | Moria, Inc. | 1998-08-25 | 99 | 0 |
| K981741 | CARRIAZO BARRAQUER MICROKERATOME | Moria, Inc. | 1998-07-24 | 67 | 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