# K253976: iLet ACE Pump

- Pathway: 510(k) (Traditional)
- Applicant: Beta Bionics, Inc.
- Decided: Apr 30, 2026 after 139 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: 5 generations back to DEN180058 (2019). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252770: iLet ACE Pump, Beta Bionics, Inc. (2025) Summary page 5.

## 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 (iCGM) 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/K253976
Methodology: https://510kreport.com/methodology