Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Meditec, 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) |
|---|---|---|---|---|---|
| K854833 | MDS-83 IN DERMATOLOGICAL/PLASTIC SURGERY APPLICATI | Meditec, Inc. | 1986-04-04 | 126 | 0 |
| K852234 | MDS 83 OPHTHALMIC DYE LASER SYSTEM | Meditec, Inc. | 1985-08-01 | 71 | 0 |
| K832983 | DERMOLAS | Meditec, Inc. | 1984-04-23 | 234 | 0 |
| K837030 | MODEL ML-4000 OPHTHALMIC LASER WITH FIBER OPTIC DELIVERY SYS | Meditec, Inc. | 1983-01-24 | 35 | 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