Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Kaiyan Medical CO , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
257 daysmedian FDA review time
327 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220168 | Skin Care Beauty Mask (Model: MJ-06) | Shenzhen Kaiyan Medical CO , Ltd. | 2022-05-17 | 117 | 0 |
| K213024 | Oren LED Perioral Light Therapy System | Shenzhen Kaiyan Medical CO , Ltd. | 2021-12-22 | 92 | 0 |
| K203214 | DemarkQ WOW, DemarkQ POP | Shenzhen Kaiyan Medical CO , Ltd. | 2021-07-22 | 262 | 0 |
| K203271 | Aduro light therapy Handheld | Shenzhen Kaiyan Medical CO , Ltd. | 2021-07-21 | 257 | 0 |
| K202390 | Aduro Light Beauty Mask | Shenzhen Kaiyan Medical CO , Ltd. | 2021-07-14 | 327 | 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