# K260001: Mint ACE Pump

- Pathway: 510(k) (Traditional)
- Applicant: Beta Bionics, Inc.
- Decided: Sep 11, 2026 after 252 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN180058 (2019). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231826: Omnipod 5 ACE Pump, Insulet Corporation (2023) Summary page 5.

## Indications for use
The Mint ACE Pump (Mint pump) is intended for the subcutaneous delivery of insulin for the management of diabetes mellitus in persons requiring insulin. The Mint pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Mint ACE Pump is intended for the management of diabetes mellitus in people 6 years of age or older. The Mint pump is intended for single-person, home use and requires a prescription.

Source page: https://510kreport.com/device/K260001
Methodology: https://510kreport.com/methodology