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The Tracker / September 2026 / K260062

510(k) cleared

MODI System

DreaMed Diabetes, Ltd. · Sep 8, 2026 · K260062

FDA cleared the MODI System from DreaMed Diabetes, Ltd. on Sep 8, 2026 under K260062, a traditional 510(k). The device falls under product code QRX, Continuous Glucose Monitor Informed Insulin Dose Calculator, regulated at 21 CFR 862.1358 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jan 8, 2026. The decision came 243 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for DreaMed Diabetes, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260062?

K260062 is the FDA 510(k) for MODI System, submitted by DreaMed Diabetes, Ltd.. FDA's decision date was Sep 8, 2026, under product code QRX (Continuous Glucose Monitor Informed Insulin Dose Calculator).

Who makes the MODI System?

DreaMed Diabetes, Ltd., based in Petah Tikva, is the applicant of record for K260062.

How long did the K260062 review take?

FDA received the submission on Jan 8, 2026 and issued its decision on Sep 8, 2026, 243 days later.

← All decisions in September 2026