# K231485: iLet® ACE Pump

- Pathway: 510(k) (Special)
- Applicant: Beta Bionics, Inc.
- Decided: Jun 21, 2023 after 29 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN180058 (2019). 3 ancestors in all.
2 later devices descend 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)
- K223846: iLet® ACE Pump, Beta Bionics, Inc. (2023) Summary page 4.

## Most influential descendants
- K252770: iLet ACE Pump (2025), 1 descendant of its own
- K253976: iLet ACE Pump (2026), 0 descendants of its own

## Recalls of this device
- Aug 13, 2025 · Class II · Z-1809-2026: it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar t

## 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/K231485
Methodology: https://510kreport.com/methodology