Xuzhou Yongkang Electronic Science Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Xuzhou Yongkang Electronic Science Technology Co., Ltd.” (first 2017, latest 2026), across 5 product codes in 5 review panels. Median 510(k) review time under this name: 228 days. Since 2017 the median was 228 days, against 137 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 |
|---|---|---|
| 2017 | 1 | 298 |
| 2018 | 2 | 346 |
| 2019 | 1 | 97 |
| 2020 | 1 | 237 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 218 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Xuzhou Yongkang Electronic Science Technology Co., Ltd. took a median 228 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FTC | Light, Ultraviolet, Dermatological | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
Review panels
- Cardiovascular (2)
- Anesthesiology (1)
- General Hospital (1)
- Radiology (1)
- General and Plastic Surgery (1)
Most recent Xuzhou Yongkang Electronic Science Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252709 | Wireless Probe Type Ultrasound Scanner | IYN | 2026-04-02 | 218 |
| K191571 | UV Radiation Treatment System | FTC | 2020-02-06 | 237 |
| K183491 | Arm Blood Pressure Monitor | DXN | 2019-03-24 | 97 |
| K180314 | Infrared Thermometer | FLL | 2018-07-11 | 156 |
| K162616 | Wrist Type Blood Pressure Monitor | DXN | 2018-03-09 | 535 |
| K161938 | Fingertip Pulse Oximeter | DQA | 2017-05-08 | 298 |
Recalls
openFDA lists no recalls under a recalling firm named Xuzhou Yongkang Electronic Science 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.
- Xuzhou Kernel Medical Equipment Co., Ltd. (9 510(k)s)
- Xuzhou Full Sun Medical Products , Ltd. (8 510(k)s)
- Xuzhou Kaixin Electronic Instrument Co., Ltd. (1 510(k)s)
- Xuzhou Maicuff Technology Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Xuzhou Yongkang Electronic Science Technology Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Xuzhou Yongkang Electronic Science Technology Co., Ltd.” (first 2017, latest 2026), across 5 product codes in 5 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 Xuzhou Yongkang Electronic Science Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xuzhou Yongkang Electronic Science Technology Co., Ltd. is 228 days. Since 2017: 228 days, versus 137 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Xuzhou Yongkang Electronic Science Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); DQA (Oximeter, 1); FLL (Continuous Measurement Thermometer, 1).
Next steps
- See all 6 Xuzhou Yongkang Electronic Science Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Xuzhou Yongkang Electronic Science 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.