Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aok Tooling Limited — 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) |
|---|---|---|---|---|---|
| K220876 | AOK 95A Medical Mask (20200049) | Aok Tooling Limited | 2022-07-27 | 124 | 0 |
| K211956 | 039 Surgical Face Mask | Aok Tooling Limited | 2021-11-23 | 152 | 0 |
| K201517 | Plain Surgical Mask | Aok Tooling Limited | 2020-09-04 | 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