Wen Hao, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Wen Hao, Inc.” (first 1989, latest 1990), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 31 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EKJ | Burnisher, Operative | 3 | 3 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
Review panels
- Dental (3)
- General Hospital (2)
Most recent Wen Hao, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K893027 | PATIENT EXAM GLOVES (MFG JET FAR INDU. INC.) | LYY | 1990-01-24 | 287 |
| K893025 | EXAM GLOVES (MFG. GUEY HER ENT. CO. LTD) | LYY | 1990-01-23 | 286 |
| K885219 | DENTAL DRESSING PLIERS | EKJ | 1989-01-19 | 31 |
| K885218 | DISCARD DENTAL MIRROR | EKJ | 1989-01-19 | 31 |
| K885217 | DISCARD DENTAL EXPLORER | EKJ | 1989-01-19 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Wen Hao, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Wen Hao, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Wen Hao, Inc.” (first 1989, latest 1990), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wen Hao, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wen Hao, Inc. is 31 days.
Which FDA product codes appear under Wen Hao, Inc.?
The most frequent FDA product codes under this applicant name are EKJ (Burnisher, Operative, 3); LYY (Latex Patient Examination Glove, 2).
Next steps
- See all 5 Wen Hao, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EKJ, Wen Hao, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.