Cleared Traditional

K203774 - SmartAdjust technology

K203774 is an FDA 510(k) clearance for SmartAdjust technology, manufactured by Insulet Corporation. The device is a Class 2 Chemistry device with product code QJI cleared through the Traditional 510(k) pathway after a 400-day FDA review.

K203774 · Insulet Corporation · Chemistry device
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Jan 2022
Decision
400d
Days
Class 2
Risk

K203774 is an FDA 510(k) clearance for the SmartAdjust 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 January 27, 2022 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K203774

510(k) Number K203774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2020
Decision Date January 27, 2022
Days to Decision 400 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
312d slower than avg
Panel avg: 88d · This submission: 400d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QJI Device Classification - Class 2, Special Controls

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 K203774.
iLet® Dosing Decision Software
K220916 · Beta Bionics, Inc. · May 2023
Tidepool Loop
K203689 · Tidepool Project · Jan 2023
SmartAdjust(TM) technology
K220394 · Insulet Corporation · Aug 2022
Control-IQ Technology
K200467 · Tandem Diabetes Care, Inc. · Jun 2020
Control-IQ Technology
DEN190034 · Tandem Diabetes Care, Inc. · Dec 2019