Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kam Yuen Plastic Products , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
184 daysmedian FDA review time
247 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230107 | Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 | Kam Yuen Plastic Products , Ltd. | 2023-04-05 | 82 | 0 |
| K213027 | Laser Hair Growth Comb | Kam Yuen Plastic Products , Ltd. | 2022-05-26 | 247 | 0 |
| K213025 | Laser hair growth helmet | Kam Yuen Plastic Products , Ltd. | 2022-05-12 | 233 | 0 |
| K212907 | Aimanfun Lumea Comfort, A-2789/A-3588 | Kam Yuen Plastic Products , Ltd. | 2021-12-02 | 80 | 0 |
| K190820 | Aimanfun Lumea Comfort | Kam Yuen Plastic Products , Ltd. | 2019-10-02 | 184 | 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