Shenzhen Wisonic Medical Technology Co. , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Shenzhen Wisonic Medical Technology Co. , Ltd.” (first 2018, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 190 days. Since 2017 the median was 190 days, against 101 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 |
|---|---|---|
| 2018 | 3 | 78 |
| 2019 | 0 | — |
| 2020 | 1 | 263 |
| 2021 | 2 | 177 |
| 2022 | 0 | — |
| 2023 | 1 | 249 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen Wisonic Medical Technology Co. , Ltd. took a median 190 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 7 | 7 |
Review panels
- Radiology (7)
Most recent Shenzhen Wisonic Medical Technology Co. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230066 | Carnation series Diagnostic Ultrasound System | IYN | 2023-09-15 | 249 |
| K211886 | Clivia series Diagnostic Ultrasound System | IYN | 2021-12-02 | 164 |
| K210154 | Labat series Diagnostic Ultrasound System | IYN | 2021-07-30 | 190 |
| K191347 | Paragon XHD Diagnostic Ultrasound System | IYN | 2020-02-07 | 263 |
| K182715 | Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System | IYN | 2018-11-20 | 54 |
| K180461 | Navi e/Navi s/Navi X Diagnostic Ultrasound System | IYN | 2018-05-09 | 78 |
| K163712 | Clover 50/Clover60/Clover70 Diagnostic Ultrasound System | IYN | 2018-01-02 | 368 |
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Wisonic Medical Technology 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.
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (160 510(k)s)
- Shenzhen Dongdixin Technology Co., Ltd. (26 510(k)s)
- Shenzhen Kaiyan Medical Equipment Co., Ltd. (24 510(k)s)
- Shenzhen TPH Technology Co., Ltd. (24 510(k)s)
- Shenzhen Ulike Smart Electronics Co., Ltd. (23 510(k)s)
- Shenzhen AOJ Medical Technology Co., Ltd. (17 510(k)s)
- Shenzhen Beacon Display Technology Co., Ltd. (17 510(k)s)
- Shenzhen Med-Link Electronics Tech Co., Ltd. (14 510(k)s)
- Shenzhen RF Tech Co., Ltd. (12 510(k)s)
- Shenzhen Root Innovation Technology Co., Ltd. (12 510(k)s)
- Shenzhen Creative Industry Co., Ltd. (11 510(k)s)
- Shenzhen Jumper Medical Equipment Co., Ltd. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shenzhen Wisonic Medical Technology Co. , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Shenzhen Wisonic Medical Technology Co. , Ltd.” (first 2018, latest 2023), across 1 product code 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 Shenzhen Wisonic Medical Technology Co. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Wisonic Medical Technology Co. , Ltd. is 190 days. Since 2017: 190 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen Wisonic Medical Technology Co. , Ltd.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 7).
Next steps
- See all 7 Shenzhen Wisonic Medical Technology Co. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Shenzhen Wisonic Medical Technology 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.