Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ascensia Diabetes Care · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
252 daysmedian FDA review time
745 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2024-02-23 | 259 | 0 |
| K193407 | Contour® next GEN Blood Glucose Monitoring System | Ascensia Diabetes Care | 2021-12-23 | 745 | 1 |
| K210687 | CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2021-08-11 | 156 | 0 |
| K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT | Ascensia Diabetes Care | 2019-11-08 | 179 | 0 |
| K160682 | CONTOUR NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2016-11-17 | 252 | 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