Cleared Traditional

SmartAdjust? Technology

K241777 · Insulet Corporation · Chemistry

Aug 2024

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K241777 is an FDA 510(k) clearance for the SmartAdjust? 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 August 26, 2024, 67 days after receiving the submission on June 20, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1356.

Submission Details

510(k) Number	K241777 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2024
Decision Date	August 26, 2024
Days to Decision	67 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.