twiist system
FDA 510(k) K250930 · Deka Research & Development Corp.
510(k) numberK250930
Submission
- Device name
- twiist system
- Applicant
- Deka Research & Development Corp.
Manchester, NH, US - Received
- March 28, 2025
- Decision date
- April 2, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K234027 | embecta Insulin Delivery SystemQFG · Traditional | Embecta Medical I, LLC | 08/30/2024SE |
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| K243354 | Remunity SystemQJY · Special | 11/27/2024SE |
| K191313 | Unity Subcutaneous Infusion System for RemodulinQJY · Traditional | 02/21/2020SE |
| K190182 | Unity Subcutaneous Delivery System for RemodulinFRN · Traditional | 05/06/2019SE |
| K172601 | Next Generation iBOTIMK · Traditional | 03/02/2018SE |
| K153760 | Volumetric Infusion ControllerLDR · Traditional | 10/03/2016SE |
| K124018 | Amia Automated PD SystemFKX · Traditional | 06/14/2013SE |
| K093915 | Deka Tac DeviceFIG · Traditional | 08/23/2011SE |
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Questions and answers
When was twiist system cleared by the FDA?
twiist system (K250930) received a 510(k) decision of Substantially Equivalent on April 2, 2025, 5 days after the submission was received.
What is the product code of K250930?
The FDA product code is QFG – Alternate Controller Enabled Insulin Infusion Pump, a Class II (moderate risk) device regulated under 21 CFR 880.5730.