Cleared Special

iLet ACE Pump

K252770 · Beta Bionics, Inc. · Chemistry

Sep 2025

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K252770 is an FDA 510(k) clearance for the iLet ACE Pump, a Alternate Controller Enabled Insulin Infusion Pump (Class II — Special Controls, product code QFG), submitted by Beta Bionics, Inc. (Concord, US). The FDA issued a Cleared decision on September 29, 2025, 27 days after receiving the submission on September 2, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5730.

Submission Details

510(k) Number	K252770 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2025
Decision Date	September 29, 2025
Days to Decision	27 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QFG — Alternate Controller Enabled Insulin Infusion Pump
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5730
Definition	An Alternate Controller Enabled Insulin Infusion Pump (ace Insulin Pump) Is A Device Intended For The Infusion Of Insulin Into A Patient. The Ace Insulin Pump May Include Basal And Bolus Drug Delivery At Set Or Variable Rates. Ace Insulin Pumps Are Designed To Reliably And Securely Communicate With External Devices, Such As Automated Insulin Dosing Systems, To Allow Insulin Delivery Commands To Be Received, Executed, And Confirmed. Ace Insulin Pumps Are Intended To Be Used Both Alone And In Conjunction With Digitally Connected Medical Devices For The Purpose Of Insulin Delivery.