Ascensia Diabetes Care U.S., Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Ascensia Diabetes Care U.S., Inc.” (first 2016, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 67 days. Since 2017 the median was 62 days, against 162 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 129 |
| 2017 | 1 | 143 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 57 |
| 2023 | 0 | — |
| 2024 | 2 | 61 |
| 2025 | 1 | 58 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ascensia Diabetes Care U.S., Inc. took a median 62 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 4 | 4 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 2 | 2 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | 1 | 1 |
Review panels
Most recent Ascensia Diabetes Care U.S., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250813 | MICROLET®NEXT 2 Lancing Device | QRL | 2025-05-14 | 58 |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System | NBW | 2024-08-27 | 67 |
| K241810 | MICROLET®NEXT Lancet | QRK | 2024-08-15 | 55 |
| K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring System | NBW | 2022-11-18 | 23 |
| K220633 | MICROLET NEXT lancing device, MICROLET Lancet | QRL | 2022-06-03 | 91 |
| K162336 | Contour Next EZ Blood Glucose Monitoring System | NBW | 2017-01-12 | 143 |
| K160430 | Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System | NBW | 2016-06-24 | 129 |
Recalls
openFDA lists no recalls under a recalling firm named Ascensia Diabetes Care U.S., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ascensia Diabetes Care (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ascensia Diabetes Care U.S., Inc.?
FDA lists 7 510(k) clearances under the applicant name “Ascensia Diabetes Care U.S., Inc.” (first 2016, latest 2025), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ascensia Diabetes Care U.S., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ascensia Diabetes Care U.S., Inc. is 67 days. Since 2017: 62 days, versus 162 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ascensia Diabetes Care U.S., Inc.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 4); QRL (Multiple Use Blood Lancet For Single Patient Use Only, 2); QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature, 1).
Next steps
- See all 7 Ascensia Diabetes Care U.S., Inc. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Ascensia Diabetes Care U.S., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.