Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Bioeasy Biotechnology Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
60 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230238 | BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch M | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2023-03-31 | 60 | 0 |
| K193480 | BIOEASY Multi-Drug Test Cup | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2020-01-31 | 46 | 0 |
| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test D | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019-10-11 | 28 | 0 |
| K192301 | BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Stri | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019-09-20 | 28 | 0 |
| K182530 | BIOEASY Multi-Drug Test Cup | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2018-11-09 | 56 | 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