Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Anrei Medical (Hangzhou) Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
182 daysmedian FDA review time
288 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212999 | Multi-Functional Electrosurgical Knife | Anrei Medical (Hangzhou) Co., Ltd. | 2022-03-21 | 182 | 0 |
| K210917 | Single Use Injection Needle | Anrei Medical (Hangzhou) Co., Ltd. | 2021-05-28 | 60 | 0 |
| K202987 | Rescue Pulmonary Grasping Forceps | Anrei Medical (Hangzhou) Co., Ltd. | 2021-04-29 | 211 | 0 |
| K210660 | Stone Retrieval Balloon Catheter | Anrei Medical (Hangzhou) Co., Ltd. | 2021-04-27 | 54 | 0 |
| K201771 | Single Use Rotatable and Repositionable Hemoclip | Anrei Medical (Hangzhou) Co., Ltd. | 2020-10-19 | 112 | 0 |
| K192048 | Single Use Endoscope Valves Set | Anrei Medical (Hangzhou) Co., Ltd. | 2020-05-14 | 288 | 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