Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Modern Healthcare Corp. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201549 | Motex Anti-Fog Surgical Face Mask | Modern Healthcare Corp. | 2020-08-26 | 78 | 0 |
| K191898 | Sterile Latex Powder-Free Surgical Gloves | Modern Healthcare Corp. | 2019-12-18 | 155 | 0 |
| K063043 | SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP | Modern Healthcare Corp. | 2007-03-21 | 169 | 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