MODI System— 510(k) K260062

Name: FDA 510(k) clearance K260062
Creator: U.S. Food and Drug Administration
Published: 2026-09-08

Substantially Equivalent

DreaMed Diabetes, Ltd.

FDA 510(k) clearance K260062 for MODI System, Substantially Equivalent on 2026-09-08. Applicant: DreaMed Diabetes, Ltd.. Device class: 2.

Summary

MODI System from DreaMed Diabetes is filed under QRX, continuous glucose monitor informed insulin dose calculators. The record doesn't describe its inputs or outputs beyond that code name.

Class II, 21 CFR 862.1358. Clinical Chemistry is both the classification panel and the review panel, and it came in as a Traditional 510(k).

DreaMed filed from Petah Tikva, Israel. Review took 243 calendar days (January 8 to September 8, 2026).

Clearance details

Applicant: DreaMed Diabetes, Ltd.
Product code: Product code QRX
Device class: Class 2
Regulation: 21 CFR 862.1358
Advisory panel: Clinical Chemistry
Date received: 2026-01-08
Decision date: 2026-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petah Tikva, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.