Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
White Knight Healthcare, Inc. · 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) |
|---|---|---|---|---|---|
| K001892 | WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHO | White Knight Healthcare, Inc. | 2001-04-03 | 286 | 0 |
| K001893 | WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODE | White Knight Healthcare, Inc. | 2001-04-02 | 285 | 0 |
| K001997 | WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) | White Knight Healthcare, Inc. | 2001-04-02 | 276 | 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