Accu-Chek Solo micropump system with interoperable technology
FDA 510(k) K213134 · Roche Diabetes Care GmbH
Submission
- Device name
- Accu-Chek Solo micropump system with interoperable technology
- Applicant
- Roche Diabetes Care GmbH
Mannheim, DE - Received
- September 27, 2021
- Decision date
- August 10, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QFG – Alternate Controller Enabled Insulin Infusion Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5730
- Specialty
- Clinical Chemistry
An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to…
Other 510(k)s with product code QFG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260001 | Mint ACE PumpQFG · Traditional | Beta Bionics, Inc. | 09/11/2026SE |
| K261672 | twiist Automated Insulin Delivery (AID) SystemQFG · Special | Deka Research and Development | 06/17/2026SE |
| K253976 | iLet ACE PumpQFG · Traditional | Beta Bionics, Inc. | 04/30/2026SE |
| K253743 | MiniMed Flex pumpQFG · Traditional | Medtronic Minimed, Inc. | 03/12/2026SE |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)QFG · Traditional | Medtronic Minimed, Inc. | 01/15/2026SE |
| K253074 | Tandem Mobi insulin pump with interoperable technologyQFG · Traditional | Tandem Diabetes Care, Inc. | 11/06/2025SE |
| K252770 | iLet ACE PumpQFG · Special | Beta Bionics, Inc. | 09/29/2025SE |
| K250792 | t:slim X2 insulin pump with interoperable technologyQFG · Traditional | Tandem Diabetes Care, Inc. | 09/24/2025SE |
| K251032 | MiniMed 780G insulin pumpQFG · Traditional | Medtronic Minimed, Inc. | 07/01/2025SE |
| K250930 | twiist systemQFG · Special | Deka Research & Development Corp. | 04/02/2025SE |
More from Deka Research & Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K232509 | Accu-Chek Safe-T-Pro Uno Lancing DeviceFMK · Traditional | 11/13/2023SE |
| K232488 | Accu-Chek Safe-T-Pro Plus Lancing DeviceFMK · Traditional | 11/13/2023SE |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemNBW · Traditional | 08/10/2023SE |
| K220849 | Accu-Chek Safe-T-Pro Plus Lancing DeviceFMK · Traditional | 05/19/2022SE |
| K203711 | IWL2020 Blood Glucose Monitoring SystemNBW · Traditional | 05/06/2022SE |
| K220608 | Accu-Chek FastClix Blood Lancing SystemQRL · Traditional | 04/29/2022SE |
| K220364 | Accu-Chek Safe-T-Pro Uno Lancing DeviceFMK · Traditional | 04/05/2022SE |
| K214022 | Accu-Chek Softclix Blood Lancing SystemQRL · Traditional | 02/17/2022SE |
| K181131 | Accu-Chek Guide Me Blood Glucose Monitoring SystemNBW · Special | 12/13/2018SE |
| K160944 | ACCU-CHEK Guide Blood Glucose Monitoring SystemNBW · Traditional | 08/31/2016SE |
Questions and answers
When was Accu-Chek Solo micropump system with interoperable technology cleared by the FDA?
Accu-Chek Solo micropump system with interoperable technology (K213134) received a 510(k) decision of Substantially Equivalent on August 10, 2023, 682 days after the submission was received.
What is the product code of K213134?
The FDA product code is QFG – Alternate Controller Enabled Insulin Infusion Pump, a Class II (moderate risk) device regulated under 21 CFR 880.5730.