Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shangdong Huamei Technology Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
84 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230816 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | 2023-04-21 | 28 | 0 |
| K202758 | Nd: YAG Laser Therapy Systems HM-YL900 | Shangdong Huamei Technology Co., Ltd. | 2020-11-16 | 56 | 0 |
| K200751 | Photodynamic Therapy (PDT) Equipment | Shangdong Huamei Technology Co., Ltd. | 2020-05-21 | 59 | 0 |
| K192521 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | 2019-12-06 | 84 | 0 |
| K192528 | CO2 Laser Therapy System | Shangdong Huamei Technology Co., Ltd. | 2019-12-03 | 81 | 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