# K252770: iLet ACE Pump

- Pathway: 510(k) (Special)
- Applicant: Beta Bionics, Inc.
- Decided: Sep 29, 2025 after 27 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: 2 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231485: iLet® ACE Pump, Beta Bionics, Inc. (2023) Summary page 4.

## Most influential descendants
- K253976: iLet ACE Pump (2026), 0 descendants of its own

## Recalls of this device
- Mar 12, 2026 · Class II · Z-1996-2026: insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/r
- Sep 23, 2025 · Class II · Z-2513-2026: The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unloc

## Indications for use
The iLet ACE Pump is an alternate controller enabled (ACE) pump intended to deliver insulin under the skin based on input from an integrated continuous glucose monitor (CGM) and an interoperable automated glycemic controller (iAGC), in people 6 years of age or older with diabetes mellitus. The iLet ACE Pump is intended for single-person use; it is not to be shared.

Source page: https://510kreport.com/device/K252770
Methodology: https://510kreport.com/methodology