# K223846: iLet® ACE Pump

- Pathway: 510(k) (Traditional)
- Applicant: Beta Bionics, Inc.
- Decided: May 19, 2023 after 150 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: 2 generations back to DEN180058 (2019). 2 ancestors in all.
3 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)
- K201214: t:slim X2 Insulin Pump with Interoperable Technology, Tandem Diabetes Care, Inc. (2020) Summary page 4.

## Most influential descendants
- K231485: iLet® ACE Pump (2023), 2 descendants of its own
- K252770: iLet ACE Pump (2025), 1 descendant of its own
- K253976: iLet ACE Pump (2026), 0 descendants of its own

## 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/K223846
Methodology: https://510kreport.com/methodology