Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
182 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241022 | Sterile single use tip cleaner (WK800-S10 , WK800-S20) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2024-07-11 | 87 | 0 |
| K222828 | Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2023-03-20 | 182 | 0 |
| K172578 | Equipment Pouch | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017-12-07 | 101 | 0 |
| K172794 | Suction Irrigation Set | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017-11-29 | 75 | 0 |
| K172038 | Trocar | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017-10-27 | 114 | 0 |
| K172120 | Veress Needle | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017-09-14 | 63 | 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