Roche Diabetes Care, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Roche Diabetes Care, Inc.” (first 2015, latest 2023), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 88 days, against 120 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.
Caduvo groups this applicant name under Roche Diagnostics, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 61 |
| 2016 | 1 | 148 |
| 2017 | 0 | — |
| 2018 | 1 | 227 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 5 | 57 |
| 2023 | 4 | 385 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Roche Diabetes Care, Inc. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 4 | 4 |
| NBW | System, Test, Blood Glucose, Over The Counter | 4 | 4 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 2 | 2 |
| NDC | Calculator, Drug Dose | 1 | 1 |
| QFG | Alternate Controller Enabled Insulin Infusion Pump | 1 | 1 |
Review panels
Most recent Roche Diabetes Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232509 | Accu-Chek Safe-T-Pro Uno Lancing Device | FMK | 2023-11-13 | 87 |
| K232488 | Accu-Chek Safe-T-Pro Plus Lancing Device | FMK | 2023-11-13 | 88 |
| K213134 | Accu-Chek Solo micropump system with interoperable technology | QFG | 2023-08-10 | 682 |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | NBW | 2023-08-10 | 682 |
| K220849 | Accu-Chek Safe-T-Pro Plus Lancing Device | FMK | 2022-05-19 | 57 |
| K203711 | IWL2020 Blood Glucose Monitoring System | NBW | 2022-05-06 | 501 |
| K220608 | Accu-Chek FastClix Blood Lancing System | QRL | 2022-04-29 | 58 |
| K220364 | Accu-Chek Safe-T-Pro Uno Lancing Device | FMK | 2022-04-05 | 56 |
| K214022 | Accu-Chek Softclix Blood Lancing System | QRL | 2022-02-17 | 57 |
| K181131 | Accu-Chek Guide Me Blood Glucose Monitoring System | NBW | 2018-12-13 | 227 |
2 earlier clearances. See the full list in Caduvo.
Recalls
29 product recalls in 15 recall events; 2 initiated in the last five years. Most recent: 2024-05-13.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Roche Diabetes Care, Inc. (a text match, not an official crosswalk):
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.
- Roche Diagnostics Corp. (456 510(k)s)
- Roche Diagnostic Systems, Inc. (296 510(k)s)
- Roche Molecular Systems, Inc. (52 510(k)s)
- Roche Medical Electronics, Inc. (16 510(k)s)
- Roche Diagnostics Operations (Rdo) (14 510(k)s)
- Roche Analytical Instruments, Inc. (11 510(k)s)
- Roche Diagnostics Operations (7 510(k)s)
- Roche Diagnostics/Boehringer Mannheim GmbH (3 510(k)s)
- Roche (2 510(k)s)
- Roche Professional Diagnostics (2 510(k)s)
- Roche Diabetes Care AG (1 510(k)s)
- Roche Diagnostics Hematology, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Roche Diabetes Care, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Roche Diabetes Care, Inc.” (first 2015, latest 2023), across 5 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 Roche Diabetes Care, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Roche Diabetes Care, Inc. is 88 days. Since 2017: 88 days, versus 120 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Roche Diabetes Care, Inc.?
The most frequent FDA product codes under this applicant name are FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, 4); NBW (System, Test, Blood Glucose, Over The Counter, 4); QRL (Multiple Use Blood Lancet For Single Patient Use Only, 2).
Next steps
- See all 12 Roche Diabetes Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMK, Roche Diabetes Care, 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.