Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioview , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
211 daysmedian FDA review time
415 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130775 | DUET SYSTEM | Bioview , Ltd. | 2014-05-09 | 415 | 0 |
| K061602 | DUET SYSTEM | Bioview , Ltd. | 2007-01-23 | 229 | 0 |
| K050840 | MODIFICATION TO DUET SYSTEM | Bioview , Ltd. | 2005-08-16 | 137 | 0 |
| K040591 | DUET SYSTEM | Bioview , Ltd. | 2004-09-16 | 192 | 0 |
| K030192 | DUET SYSTEM | Bioview , Ltd. | 2003-08-20 | 211 | 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