DEKA ACE Pump System
FDA 510(k) K213536 · Deka Research and Development
510(k) numberK213536
Submission
- Device name
- DEKA ACE Pump System
- Applicant
- Deka Research and Development
Manchester, NH, US - Received
- November 5, 2021
- Decision date
- July 25, 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…
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|---|---|---|---|
| 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 |
|---|---|---|
| K261672 | twiist Automated Insulin Delivery (AID) SystemQFG · Special | 06/17/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | 06/03/2026SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | 08/01/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | 01/16/2025SE |
| K242693 | DEKA Infusion System, DEKA Administration SetLDR · Special | 10/07/2024SE |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS)KPO · Traditional | 07/12/2024SE |
| K233557 | HemoCare Hemodialysis SystemKDI · Traditional | 07/12/2024SE |
| K240256 | Remunity SystemQJY · Traditional | 06/12/2024SE |
| K241178 | DEKA ACE Pump SystemQFG · Special | 05/24/2024SE |
| K234055 | DEKA LoopQJI · Traditional | 03/13/2024SE |
Questions and answers
When was DEKA ACE Pump System cleared by the FDA?
DEKA ACE Pump System (K213536) received a 510(k) decision of Substantially Equivalent on July 25, 2023, 627 days after the submission was received.
What is the product code of K213536?
The FDA product code is QFG – Alternate Controller Enabled Insulin Infusion Pump, a Class II (moderate risk) device regulated under 21 CFR 880.5730.