Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ascensia Diabetes Care U.S., Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
143 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250813 | MICROLET®NEXT 2 Lancing Device | Ascensia Diabetes Care U.S., Inc. | 2025-05-14 | 58 | 0 |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® | Ascensia Diabetes Care U.S., Inc. | 2024-08-27 | 67 | 0 |
| K241810 | MICROLET®NEXT Lancet | Ascensia Diabetes Care U.S., Inc. | 2024-08-15 | 55 | 0 |
| K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | 2022-11-18 | 23 | 0 |
| K220633 | MICROLET NEXT lancing device, MICROLET Lancet | Ascensia Diabetes Care U.S., Inc. | 2022-06-03 | 91 | 0 |
| K162336 | Contour Next EZ Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | 2017-01-12 | 143 | 0 |
| K160430 | Contour Next Link Wireless Blood Glucose Monitoring System, | Ascensia Diabetes Care U.S., Inc. | 2016-06-24 | 129 | 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