Cleared Traditional

Control-IQ Technology (K200467) - FDA 510(k) Clearance

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

K200467 · Tandem Diabetes Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
111d
Days
Class 2
Risk

K200467 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 June 16, 2020 after a review of 111 days - within the typical 510(k) review window.

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 Tandem Diabetes Care, Inc. devices

Submission Details

510(k) Number K200467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2020
Decision Date June 16, 2020
Days to Decision 111 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
23d slower than avg
Panel avg: 88d · This submission: 111d
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
NCT02679287 Completed Interventional

Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control

103
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Diabetes Mellitus, Type 1
Study design Crossover
Eligibility All sexes · 18 Years+
Principal investigator Sue A. Brown, MD
Sponsor University of Virginia
Started 2016-02-01 → Primary completion 2019-04-01
Primary outcome
Time <70 mg/dl by CGM
Secondary outcome
Time Between 70-180 mg/dL by CGM
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 K200467.
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