iLet ACE Pump
FDA 510(k) K253976 · Beta Bionics, Inc.
510(k) numberK253976
Submission
- Device name
- iLet ACE Pump
- Applicant
- Beta Bionics, Inc.
Concord, MA, US - Received
- December 12, 2025
- Decision date
- April 30, 2026
- 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 |
| 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 |
| K234027 | embecta Insulin Delivery SystemQFG · Traditional | Embecta Medical I, LLC | 08/30/2024SE |
More from Embecta Medical I, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K262763 | iLet Dosing Decision SoftwareQJI · Traditional | 09/11/2026SE |
| K260001 | Mint ACE PumpQFG · Traditional | 09/11/2026SE |
| K252770 | iLet ACE PumpQFG · Special | 09/29/2025SE |
| K232224 | iLet® Dosing Decision SoftwareQJI · Traditional | 09/22/2023SE |
| K231485 | iLet® ACE PumpQFG · Special | 06/21/2023SE |
| K223846 | iLet® ACE PumpQFG · Traditional | 05/19/2023SE |
| K220916 | iLet® Dosing Decision SoftwareQJI · Traditional | 05/19/2023SE |
Questions and answers
When was iLet ACE Pump cleared by the FDA?
iLet ACE Pump (K253976) received a 510(k) decision of Substantially Equivalent on April 30, 2026, 139 days after the submission was received.
What is the product code of K253976?
The FDA product code is QFG – Alternate Controller Enabled Insulin Infusion Pump, a Class II (moderate risk) device regulated under 21 CFR 880.5730.