Cleared Traditional

iLet? ACE Pump

K223846 · Beta Bionics, Inc. · Chemistry

May 2023

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K223846 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 May 19, 2023, 150 days after receiving the submission on December 20, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5730.

Submission Details

510(k) Number	K223846 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2022
Decision Date	May 19, 2023
Days to Decision	150 days
Submission Type	Traditional
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.