Cleared Traditional

K243823 - Control-IQ+ technology (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence.

K243823 · Tandem Diabetes Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
74d
Days
Class 2
Risk

K243823 is an FDA 510(k) clearance for the Control-IQ+ technology. Classified as Interoperable Automated Glycemic Controller (product code QJI), Class II - Special Controls.

Submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Cleared decision on February 24, 2025 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tandem Diabetes Care, Inc. devices

Submission Details

510(k) Number K243823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2024
Decision Date February 24, 2025
Days to Decision 74 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
14d faster than avg
Panel avg: 88d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05785832 Completed Interventional Industry-sponsored

A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 Diabetes

A Randomized Trial Evaluating the Efficacy and Safety of Control-IQ+ Technology in Adults With Type 2 Diabetes Using Basal-Bolus Insulin Therapy (2IQP)

319
Patients (actual)
21
Sites
Treatment
Purpose
Open label
Masking
Condition studied Type 2 Diabetes Treated With Insulin
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Jordan Pinsker, MD
Sponsor Tandem Diabetes Care, Inc. (industry)
Started 2023-06-01 → Primary completion 2024-09-24
Primary outcome
HbA1c
Secondary outcome
Time in Range 70-180 mg/dL
View full study on ClinicalTrials.gov

Regulatory Peers - QJI Interoperable Automated Glycemic Controller

All 19
Devices cleared under the same product code (QJI) and FDA review panel - the closest regulatory comparables to K243823.
Control-IQ+ technology
K260429 · Tandem Diabetes Care, Inc. · Apr 2026
SmartGuard Technology
K253701 · Medtronic Minimed · Feb 2026
SmartGuard technology
K253585 · Medtronic Minimed, Inc. · Jan 2026
DBLG2
K251152 · Diabeloop · Dec 2025
Omnipod 5 algorithm
K251779 · Insulet Corporation · Dec 2025
SmartGuard technology
K251217 · Medtronic Minimed, Inc. · Aug 2025