Wuxi Hisky Medical Technologies Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Wuxi Hisky Medical Technologies Co., Ltd.” (first 2018, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 213 days. Since 2017 the median was 213 days, against 100 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 | 1 | 213 |
| 2019 | 0 | — |
| 2020 | 1 | 56 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 3 | 234 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wuxi Hisky Medical Technologies Co., Ltd. took a median 213 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| OWN | Confocal Optical Imaging | 1 | 1 |
Review panels
Most recent Wuxi Hisky Medical Technologies Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250026 | Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) | IYN | 2025-10-01 | 268 |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); | OWN | 2025-07-24 | 234 |
| K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | IYO | 2025-06-17 | 181 |
| K200136 | Shear Wave Quantificational Ultrasound Diagnostic System | IYO | 2020-03-17 | 56 |
| K173595 | Shear Wave Quantificational Ultrasound Diagnostic System | IYO | 2018-06-22 | 213 |
Recalls
openFDA lists no recalls under a recalling firm named Wuxi Hisky Medical Technologies 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.
- Wuxi Jiajian Medical Instrument Co., Ltd. (12 510(k)s)
- Wuxi Nest Biotechnology Co., Ltd. (4 510(k)s)
- Wuxi Xinzhongrui Baby Supplies Co., Ltd. (3 510(k)s)
- Wuxi Yushou Medical Applicances Co., Ltd. (3 510(k)s)
- Wuxi EA Medical Instruments Technologies Limited. (2 510(k)s)
- Wuxi Shenzhou Plastic Products Co., Ltd. (2 510(k)s)
- Wuxi Yushou Medical Appliances Co., Ltd. (2 510(k)s)
- Wuxi Beien Surgery Device Co., Ltd. (1 510(k)s)
- Wuxi Bingfa Gainlite Gloves Cp., Ltd. (1 510(k)s)
- Wuxi Exanovo Medical Instrument Co., Ltd. (1 510(k)s)
- Wuxi Medical Instrument Factory (1 510(k)s)
- Wuxi Shukang Medical Appliance Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wuxi Hisky Medical Technologies Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Wuxi Hisky Medical Technologies Co., Ltd.” (first 2018, latest 2025), across 3 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 Wuxi Hisky Medical Technologies Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wuxi Hisky Medical Technologies Co., Ltd. is 213 days. Since 2017: 213 days, versus 100 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wuxi Hisky Medical Technologies Co., Ltd.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 3); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 1); OWN (Confocal Optical Imaging, 1).
Next steps
- See all 5 Wuxi Hisky Medical Technologies Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Wuxi Hisky Medical Technologies 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.