Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Makrite Industries, 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) |
|---|---|---|---|---|---|
| K252650 | Disposable Medical Face Mask | Makrite Industries, Inc. | 2026-01-05 | 136 | 0 |
| K240258 | Disposable Medical Face Mask (M643BE) | Makrite Industries, Inc. | 2024-04-18 | 78 | 0 |
| K220550 | Disposable Surgical Face Mask (M663BE, M663BT) | Makrite Industries, Inc. | 2022-06-14 | 109 | 0 |
| K020474 | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 | Makrite Industries, Inc. | 2002-07-23 | 161 | 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