Cleared Traditional

SmartAdjust(TM) technology

K232741 · Insulet Corporation · Chemistry

May 2024

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K232741 is an FDA 510(k) clearance for the SmartAdjust(TM) technology, a Interoperable Automated Glycemic Controller (Class II — Special Controls, product code QJI), submitted by Insulet Corporation (Acton, US). The FDA issued a Cleared decision on May 29, 2024, 265 days after receiving the submission on September 7, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1356.

Submission Details

510(k) Number	K232741 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 07, 2023
Decision Date	May 29, 2024
Days to Decision	265 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.