Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Vivachek Biotech (Hangzhou) Co., Ltd. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
760 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Uri | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026-05-22 | 35 | 0 |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine | Vivachek Biotech (Hangzhou) Co., Ltd. | 2025-09-12 | 30 | 0 |
| K241869 | BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-10-04 | 99 | 0 |
| K222126 | VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-08-16 | 760 | 0 |
| K240124 | BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Rea | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-06-14 | 150 | 0 |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-12-22 | 88 | 0 |
| K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Dru | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-11-02 | 37 | 0 |
| K231978 | BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-08-31 | 59 | 0 |
| K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine | Vivachek Biotech (Hangzhou) Co., Ltd. | 2022-11-10 | 65 | 0 |
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2020-06-05 | 228 | 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