Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xiamen Weiyou Intelligent Technology Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
184 daysmedian FDA review time
344 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253919 | Cryo And Thermo Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2026-06-10 | 184 | 0 |
| K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2026-04-30 | 220 | 0 |
| K243791 | Air Pressure Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2025-01-13 | 34 | 0 |
| K243320 | Air Pressure Therapy System (VU-IPC04B) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2024-11-18 | 26 | 0 |
| K233238 | Air Pressure Therapy System (Model:VU-IPC4M) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2024-06-14 | 260 | 0 |
| K201935 | Air Pressure Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2021-06-22 | 344 | 0 |
| K210967 | Air Pressure Therapy System: VU-IPC06 | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2021-05-11 | 41 | 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