Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xuzhou Kernel Medical Equipment Co., Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
142 daysmedian FDA review time
246 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261775 | Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2026-07-21 | 53 | 0 |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-40 | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-02-06 | 133 | 0 |
| K222751 | LED Light Therapy Device, KN-7000L | Xuzhou Kernel Medical Equipment Co., Ltd. | 2023-02-01 | 142 | 0 |
| K200971 | 308nm Excimer System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020-12-15 | 246 | 0 |
| K200929 | Hair Growth System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020-06-03 | 57 | 0 |
| K190685 | Hair Growth System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019-07-26 | 130 | 0 |
| K181805 | UV Phototherapy | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019-01-11 | 189 | 0 |
| K160341 | Colposcope System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2016-09-14 | 219 | 0 |
| K132643 | UV PHOTOTHERAPY | Xuzhou Kernel Medical Equipment Co., Ltd. | 2014-01-30 | 157 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda