# Roche Diabetes Care, Inc.

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 13 (2012–2023): 13 510(k) clearances
- Names in FDA's records: Roche Diabetes Care, Inc. (9); Roche Diabetes Care GmbH (2); Roche Diabetes Care (1); Roche Diabetes Care AG (1)
- Product codes: FMK (4), NBW (4), QRL (2), NDC (1), FPA (1), QFG (1)
- 510(k) review time since 2016: median 88 days, against 95 for FDA's reviews in the same codes and years (7 of 11 faster)
- Predicates its devices cite: 14 (7 its own); citations of its devices by later devices: 20 (7 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 3 (https://510kreport.com/company/roche-diagnostics)
- Medipurpose Pte., Ltd.: 2 (https://510kreport.com/company/medipurpose)
- Biodynamics Corp.: 1 (https://510kreport.com/company/biodynamics)
- Insulet Corporation: 1 (https://510kreport.com/company/insulet)

## Firms that cite its devices most
- Stat Medical Devices: 3 (https://510kreport.com/company/stat-medical-devices)
- Gostar Co., Ltd.: 1 (https://510kreport.com/company/gostar)
- Voluntis Sa.: 1 (https://510kreport.com/company/voluntis)
- Asahi Polyslider Co., Ltd.: 1 (https://510kreport.com/company/asahi-polyslider)
- Owen Mumford, Ltd.: 1 (https://510kreport.com/company/owen-mumford)
- Sewon Medical Co.: 1 (https://510kreport.com/company/sewon-medical)
- Arkray, Inc.: 1 (https://510kreport.com/company/arkray)
- Beijing Ruicheng Medical Supplies Co., Ltd.: 1 (https://510kreport.com/company/beijing-ruicheng-medical-supplies)

## Its most-cited devices
- K214022: Accu-Chek Softclix Blood Lancing System (2022), cited by 12
- K160944: ACCU-CHEK Guide Blood Glucose Monitoring System (2016), cited by 3
- K150910: ACCU-CHEK Connect Diabetes Management App (2015), cited by 3
- K220364: Accu-Chek Safe-T-Pro Uno Lancing Device (2022), cited by 1
- K220849: Accu-Chek Safe-T-Pro Plus Lancing Device (2022), cited by 1

## Recent decisions
- K232509: Accu-Chek Safe-T-Pro Uno Lancing Device (Nov 13, 2023)
- K232488: Accu-Chek Safe-T-Pro Plus Lancing Device (Nov 13, 2023)
- K213134: Accu-Chek Solo micropump system with interoperable technology (Aug 10, 2023)
- K213131: Accu-Chek Guide Solo diabetes manager blood glucose monitoring system (Aug 10, 2023)
- K220849: Accu-Chek Safe-T-Pro Plus Lancing Device (May 19, 2022)
- K203711: IWL2020 Blood Glucose Monitoring System (May 6, 2022)
- K220608: Accu-Chek FastClix Blood Lancing System (Apr 29, 2022)
- K220364: Accu-Chek Safe-T-Pro Uno Lancing Device (Apr 5, 2022)

Source page: https://510kreport.com/company/roche-diabetes-care