Cleared Traditional

K250798 - Control-IQ+ technology (FDA 510(k) Clearance)

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

K250798 · Tandem Diabetes Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
68d
Days
Class 2
Risk

K250798 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 May 21, 2025 after a review of 68 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 K250798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2025
Decision Date May 21, 2025
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. PCCP authorized - AI/SaMD pathway.

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
NCT05403502 Completed Interventional Industry-sponsored

Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes

183
Patients (actual)
13
Sites
Treatment
Purpose
Open label
Masking
Condition studied Type 1 Diabetes
Study design Single group
Eligibility All sexes · 6 Years+
Principal investigator Jordan Pinsker, MD
Sponsor Tandem Diabetes Care, Inc. (industry)
Started 2022-08-31 → Primary completion 2023-08-02
Primary outcome
Severe Hypoglycemia
Secondary outcome
Overall Percent Time Less Than 54 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 K250798.
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