Cleared Traditional

K253701 - SmartGuard Technology (FDA 510(k) Clearance)

Also includes:
Predictive Low Glucose Technology

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253701 · Medtronic Minimed · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
71d
Days
Class 2
Risk

K253701 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 (Northridge, US). The FDA issued a Cleared decision on February 3, 2026 after a review of 71 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 Medtronic Minimed devices

Submission Details

510(k) Number K253701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2025
Decision Date February 03, 2026
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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. 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 19
Devices cleared under the same product code (QJI) and FDA review panel - the closest regulatory comparables to K253701.
Control-IQ+ technology
K260429 · Tandem Diabetes Care, Inc. · Apr 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
Control-IQ+ technology
K250798 · Tandem Diabetes Care, Inc. · May 2025