Cleared Traditional

iLet? Dosing Decision Software

K220916 · Beta Bionics, Inc. · Chemistry

May 2023

Decision

415d

Days

Class 2

Risk

About This 510(k) Submission

K220916 is an FDA 510(k) clearance for the iLet? Dosing Decision Software, a Interoperable Automated Glycemic Controller (Class II — Special Controls, product code QJI), submitted by Beta Bionics, Inc. (Concord, US). The FDA issued a Cleared decision on May 19, 2023, 415 days after receiving the submission on March 30, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1356.

Submission Details

510(k) Number	K220916 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 30, 2022
Decision Date	May 19, 2023
Days to Decision	415 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QJI — Interoperable Automated Glycemic Controller
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1356
Definition	An Interoperable Automated Glycemic Controller Is A Device Intended To Automatically Calculate Drug Doses Based On Inputs Such As Glucose And Other Relevant Physiological Parameters, And To Command The Delivery Of Such Drug Doses From A Connected Infusion Pump. Interoperable Automated Glycemic Controllers Are Designed To Reliably And Securely Communicate With Digitally Connected Devices To Allow Drug Delivery Commands To Be Sent, Received, Executed, And Confirmed. Interoperable Automated Glycemic Controllers Are Intended To Be Used In Conjunction With Digitally Connected Devices For The Purpose Of Maintaining Glycemic Control.