Cleared Traditional

K251217 - SmartGuard technology (FDA 510(k) Clearance)

Also includes:
Predictive Low Glucose technology

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

K251217 · Medtronic Minimed, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
130d
Days
Class 2
Risk

K251217 is an FDA 510(k) clearance for the SmartGuard technology. Classified as Interoperable Automated Glycemic Controller (product code QJI), Class II - Special Controls.

Submitted by Medtronic Minimed, Inc. (Northridge, US). The FDA issued a Cleared decision on August 29, 2025 after a review of 130 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 Medtronic Minimed, Inc. devices

Submission Details

510(k) Number K251217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2025
Decision Date August 29, 2025
Days to Decision 130 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
42d slower than avg
Panel avg: 88d · This submission: 130d
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
NCT01991470 Completed Interventional Industry-sponsored

CEP249 Pediatric Accuracy Study

A Performance Evaluation of the Enlite™ and Enlite 3 Glucose Sensor to Support Use in Children

186
Patients (actual)
11
Sites
Treatment
Purpose
Open label
Masking
Condition studied Insulin Requiring Diabetes
Study design Sequential
Eligibility All sexes · 2 Years+
Principal investigator Ronald Brazg, MD
Sponsor Medtronic MiniMed, Inc. (industry)
Started 2015-03-01 → Primary completion 2016-12-01
Primary outcome
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump
Secondary outcome
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter
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 K251217.
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
Control-IQ+ technology
K250798 · Tandem Diabetes Care, Inc. · May 2025