Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hangzhou Bever Medical Devices Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192468 | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, | Hangzhou Bever Medical Devices Co., Ltd. | 2019-11-27 | 79 | 1 |
| K111401 | BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE | Hangzhou Bever Medical Devices Co., Ltd. | 2012-07-19 | 427 | 0 |
| K111406 | BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), B | Hangzhou Bever Medical Devices Co., Ltd. | 2012-07-19 | 427 | 0 |
| K111405 | BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON- | Hangzhou Bever Medical Devices Co., Ltd. | 2012-02-13 | 270 | 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