Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medart Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
183 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010885 | UNI-LASER 470 | Medart Corp. | 2001-06-07 | 76 | 0 |
| K000503 | MEDART 520 COOLING SYSTEM | Medart Corp. | 2000-05-15 | 90 | 0 |
| K993815 | UNI-LASER 430 | Medart Corp. | 2000-05-11 | 183 | 0 |
| K991659 | UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES | Medart Corp. | 1999-07-29 | 76 | 0 |
| K991297 | UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES | Medart Corp. | 1999-07-12 | 88 | 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