Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wepon Medical Technology Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
166 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231720 | Sterile Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | 2023-09-08 | 87 | 0 |
| K231727 | Sterile Auto-Disable Syringes with/without Needle for Single | Wepon Medical Technology Co., Ltd. | 2023-09-08 | 87 | 0 |
| K231729 | Sterile syringes for single use with/without needle | Wepon Medical Technology Co., Ltd. | 2023-09-08 | 87 | 0 |
| K231723 | Sterile Safety Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | 2023-09-08 | 87 | 0 |
| K212299 | Medical Surgical Mask | Wepon Medical Technology Co., Ltd. | 2022-01-04 | 166 | 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