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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alternate Controller Enabled Insulin Infusion Pump
510(k) Number K223846
FOIA Releasable 510(k) K223846
Device Name iLet® ACE Pump
Applicant
Beta Bionics, Inc.
300 Baker Ave., Suite 301
Concord,  MA  01742
Applicant Contact Vikram Verma
Correspondent
Beta Bionics, Inc.
300 Baker Ave., Suite 301
Concord,  MA  01742
Correspondent Contact Vikram Verma
Regulation Number880.5730
Classification Product Code
QFG  
Date Received12/20/2022
Decision Date 05/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT04200313
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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