Wuhan Zonsen Medical Products Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Wuhan Zonsen Medical Products Co., Ltd.” (first 2021, latest 2023), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 206 days. Since 2017 the median was 206 days, against 129 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2021 | 2 | 167 |
| 2022 | 3 | 175 |
| 2023 | 1 | 266 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wuhan Zonsen Medical Products Co., Ltd. took a median 206 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FXX | Mask, Surgical | 2 | 2 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Wuhan Zonsen Medical Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223600 | Sterilization Wrap | FRG | 2023-08-25 | 266 |
| K213601 | Surgical Mask | FXX | 2022-12-16 | 396 |
| K213688 | Nitrile Examination Gloves (Model: ZMG1351) | LZA | 2022-02-18 | 87 |
| K212357 | Surgical isolation gown | FYC | 2022-01-20 | 175 |
| K212861 | Surgical Gown, Reinforced Surgical Gown | FYA | 2021-12-15 | 98 |
| K202191 | Surgical Mask | FXX | 2021-03-29 | 236 |
Recalls
openFDA lists no recalls under a recalling firm named Wuhan Zonsen Medical Products Co., Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Wuhan Pioon Technology Co., Ltd. (8 510(k)s)
- Wuhan Lotuxs Technology Co., Ltd. (5 510(k)s)
- Wuhan Dymex Healthcare Co., Ltd. (4 510(k)s)
- Wuhan Dimed Laser Technology Co., Ltd. (2 510(k)s)
- Wuhan Gigaa Optronics Technology Co., Ltd. (2 510(k)s)
- Wuhan Greentek Pty , Ltd. (2 510(k)s)
- Wuhan United Imaging Healthcare Co.,Ltd (2 510(k)s)
- Wuhan Guangdun Technology Co.,Ltd.. (1 510(k)s)
- Wuhan Huashida Protective Products Co., Ltd. (1 510(k)s)
- Wuhan Huchuang Union Technology Co., Ltd. (1 510(k)s)
- Wuhan Huirui Technology Co., Ltd. (1 510(k)s)
- Wuhan Landing Medical Hi-Tech, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wuhan Zonsen Medical Products Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Wuhan Zonsen Medical Products Co., Ltd.” (first 2021, latest 2023), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wuhan Zonsen Medical Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wuhan Zonsen Medical Products Co., Ltd. is 206 days. Since 2017: 206 days, versus 129 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wuhan Zonsen Medical Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are FXX (Mask, Surgical, 2); FRG (Wrap, Sterilization, 1); FYA (Gown, Surgical, 1).
Next steps
- See all 6 Wuhan Zonsen Medical Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FXX, Wuhan Zonsen Medical Products Co., Ltd.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.