Cleared Traditional

K260062 - MODI System

K260062 is an FDA 510(k) clearance for MODI System, manufactured by DreaMed Diabetes, Ltd.. The device is a Class 2 Chemistry device with product code QRX cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K260062 · DreaMed Diabetes, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
243d
Days
Class 2
Risk

K260062 is an FDA 510(k) clearance for the MODI System. Classified as Continuous Glucose Monitor Informed Insulin Dose Calculator (product code QRX), Class II - Special Controls.

Submitted by DreaMed Diabetes, Ltd. (Petah Tikva, IL). The FDA issued a Cleared decision on September 8, 2026 after a review of 243 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1358 - 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 DreaMed Diabetes, Ltd. devices

FDA 510(k) Submission Details - K260062

510(k) Number K260062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2026
Decision Date September 08, 2026
Days to Decision 243 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 88d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QRX Device Classification - Class 2, Special Controls

Product Code QRX Continuous Glucose Monitor Informed Insulin Dose Calculator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1358
Definition A Continuous Glucose Monitor (cgm)-informed Insulin Dose Calculator Is A Software Device That Calculates Suggested Insulin Doses Based On Cgm Values And/or Other Relevant Information.
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 - QRX Continuous Glucose Monitor Informed Insulin Dose Calculator

Devices cleared under the same product code (QRX) and FDA review panel - the closest regulatory comparables to K260062.
Dexcom Smart Basal
K252818 · Dexcom, Inc. · Nov 2025
SmartBolus Calculator
K231824 · Insulet Corporation · Oct 2023
BlueStar CGM insulin dose calculator
K222888 · Welldoc, Inc. · Aug 2023
SmartBolus Calculator
K222239 · Insulet Corporation · Aug 2022
Omnipod 5 SmartBolus Calculator
K203772 · Insulet Corporation · Jan 2022