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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Glucose Monitor Informed Insulin Dose Calculator
510(k) Number K260062
Device Name MODI System
Applicant
DreaMed Diabetes, Ltd.
14 Kaplan St.
Petah Tikva,  IL 4920235
Applicant Contact Adi Berkovitch
Correspondent
DreaMed Diabetes, Ltd.
14 Kaplan St.
Petah Tikva,  IL 4920235
Correspondent Contact Adi Berkovitch
Regulation Number862.1358
Classification Product Code
QRX  
Subsequent Product Code
NDC  
Date Received01/08/2026
Decision Date 09/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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