Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kenpax International Limited · 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) |
|---|---|---|---|---|---|
| K222128 | Protective Gown AAMI Level 4 | Kenpax International Limited | 2023-08-08 | 386 | 0 |
| K222151 | Sterilization Wrap | Kenpax International Limited | 2023-03-23 | 246 | 0 |
| K212504 | Isolation Gown AAMI Level 3 | Kenpax International Limited | 2021-11-07 | 90 | 0 |
| K202899 | Procedure Mask, Surgical Mask | Kenpax International Limited | 2021-05-20 | 233 | 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