Xuzhou Kernel Medical Equipment Co., Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Xuzhou Kernel Medical Equipment Co., Ltd.” (first 2014, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 142 days. Since 2017 the median was 133 days, against 90 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 |
|---|---|---|
| 2014 | 1 | 157 |
| 2015 | 0 | — |
| 2016 | 1 | 219 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 160 |
| 2020 | 2 | 152 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 142 |
| 2024 | 0 | — |
| 2025 | 1 | 133 |
| 2026 | 1 | 53 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Xuzhou Kernel Medical Equipment Co., Ltd. took a median 133 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | 4 | 4 |
| OAP | Laser, Comb, Hair | 2 | 2 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HEX | Colposcope (And Colpomicroscope) | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Xuzhou Kernel Medical Equipment Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261775 | Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) | — | 2026-07-21 | 53 |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) | FTC | 2025-02-06 | 133 |
| K222751 | LED Light Therapy Device, KN-7000L | GEX | 2023-02-01 | 142 |
| K200971 | 308nm Excimer System | FTC | 2020-12-15 | 246 |
| K200929 | Hair Growth System | OAP | 2020-06-03 | 57 |
| K190685 | Hair Growth System | OAP | 2019-07-26 | 130 |
| K181805 | UV Phototherapy | FTC | 2019-01-11 | 189 |
| K160341 | Colposcope System | HEX | 2016-09-14 | 219 |
| K132643 | UV PHOTOTHERAPY | FTC | 2014-01-30 | 157 |
Recalls
openFDA lists no recalls under a recalling firm named Xuzhou Kernel Medical Equipment 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 Full Sun Medical Products , Ltd. (8 510(k)s)
- Xuzhou Yongkang Electronic Science Technology Co., Ltd. (6 510(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 Kernel Medical Equipment Co., Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Xuzhou Kernel Medical Equipment Co., Ltd.” (first 2014, latest 2026), across 5 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 Xuzhou Kernel Medical Equipment Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xuzhou Kernel Medical Equipment Co., Ltd. is 142 days. Since 2017: 133 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Xuzhou Kernel Medical Equipment Co., Ltd.?
The most frequent FDA product codes under this applicant name are FTC (Light, Ultraviolet, Dermatological, 4); OAP (Laser, Comb, Hair, 2); GEX (Powered Laser Surgical Instrument, 1).
Next steps
- See all 9 Xuzhou Kernel Medical Equipment Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FTC, Xuzhou Kernel Medical Equipment 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.