Cleared Traditional

K232741 - SmartAdjust(TM) technology

K232741 is the FDA 510(k) clearance for SmartAdjust(TM) technology by Insulet Corporation. It is a Class 2 Chemistry device (product code QJI) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K232741 · Insulet Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
265d
Days
Class 2
Risk

K232741 is an FDA 510(k) clearance for the SmartAdjust(TM) technology. Classified as Interoperable Automated Glycemic Controller (product code QJI), Class II - Special Controls.

Submitted by Insulet Corporation (Acton, US). The FDA issued a Cleared decision on May 29, 2024 after a review of 265 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1356 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Insulet Corporation devices

Submission Details

510(k) Number K232741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 88d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJI Interoperable Automated Glycemic Controller
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - QJI Interoperable Automated Glycemic Controller

All 20
Devices cleared under the same product code (QJI) and FDA review panel - the closest regulatory comparables to K232741.
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K250798 · Tandem Diabetes Care, Inc. · May 2025
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K243823 · Tandem Diabetes Care, Inc. · Feb 2025
SmartAdjust™ Technology
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CamAPS FX
K232603 · Camdiab , Ltd. · May 2024
DEKA Loop
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Control-IQ Technology
K232382 · Tandem Diabetes Care, Inc. · Nov 2023