Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wen Hao, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
31 daysmedian FDA review time
287 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K893027 | PATIENT EXAM GLOVES (MFG JET FAR INDU. INC.) | Wen Hao, Inc. | 1990-01-24 | 287 | 0 |
| K893025 | EXAM GLOVES (MFG. GUEY HER ENT. CO. LTD) | Wen Hao, Inc. | 1990-01-23 | 286 | 0 |
| K885217 | DISCARD DENTAL EXPLORER | Wen Hao, Inc. | 1989-01-19 | 31 | 0 |
| K885219 | DENTAL DRESSING PLIERS | Wen Hao, Inc. | 1989-01-19 | 31 | 0 |
| K885218 | DISCARD DENTAL MIRROR | Wen Hao, Inc. | 1989-01-19 | 31 | 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