Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
White Knight Healthcare · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
165 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951984 | WHITE KNIGHT SURGEON'S VEST | White Knight Healthcare | 1995-07-25 | 89 | 0 |
| K943809 | MONOGARD FACE SHIELD | White Knight Healthcare | 1994-11-28 | 116 | 0 |
| K942577 | SURGICAL TIP CLEANER | White Knight Healthcare | 1994-07-26 | 56 | 0 |
| K942576 | CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE | White Knight Healthcare | 1994-07-05 | 35 | 0 |
| K934969 | DUALGARD FACE SHIELD | White Knight Healthcare | 1994-03-28 | 165 | 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