Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wuhan Pioon Technology Co., Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
153 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243764 | Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU | Wuhan Pioon Technology Co., Ltd. | 2025-05-08 | 153 | 0 |
| K250656 | Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) | Wuhan Pioon Technology Co., Ltd. | 2025-04-04 | 30 | 0 |
| K240747 | Medical Diode Laser (M2-GK) | Wuhan Pioon Technology Co., Ltd. | 2024-06-17 | 90 | 0 |
| K240644 | Medical Diode Laser (S1Pro) | Wuhan Pioon Technology Co., Ltd. | 2024-06-10 | 95 | 0 |
| K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. | 2024-03-21 | 58 | 0 |
| K231548 | Medical Diode Laser, Model S1Pro | Wuhan Pioon Technology Co., Ltd. | 2023-08-03 | 65 | 0 |
| K230274 | Medical Diode Laser (M2) | Wuhan Pioon Technology Co., Ltd. | 2023-03-31 | 58 | 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