Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
OUK · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231741 | ProGear® Surgical Mask with Oxafence®, Model AV82030 | Prestige Ameritech | 2024-09-05 | 449 | 0 |
| K192105 | Innonix Antiviral Child's Face Mask | Innonix Technologies Limited | 2019-11-29 | 116 | 0 |
| K182766 | Cufitec Surgical Mask | Nbc Meshtec, Inc. | 2019-01-03 | 97 | 0 |
| K101128 | BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200 | Filligent Limited | 2011-05-26 | 399 | 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