Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bionime Coporation · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141292 | Rightest Blood Glucose Monitoring System GM700, Rightest Blo | Bionime Coporation | 2015-06-09 | 386 | 0 |
| K143387 | GE333 Blood Glucose Monitoring System | Bionime Coporation | 2015-06-03 | 189 | 0 |
| K133522 | RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING | Bionime Coporation | 2014-04-17 | 153 | 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