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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interoperable Automated Glycemic Controller
510(k) Number K262763
Device Name iLet Dosing Decision Software
Applicant
Beta Bionics, Inc.
11 Hughes
Irvine,  CA  92618
Applicant Contact Liz Cooper
Correspondent
Beta Bionics, Inc.
11 Hughes
Irvine,  CA  92618
Correspondent Contact Liz Cooper
Regulation Number862.1356
Classification Product Code
QJI  
Date Received08/04/2026
Decision Date 09/11/2026
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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