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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 K260001
Device Name Mint ACE Pump
Applicant
Beta Bionics, Inc.
11 Hughes
Irvine,  CA  92618
Applicant Contact Douglas Ferguson
Correspondent
Beta Bionics, Inc.
11 Hughes
Irvine,  CA  92618
Correspondent Contact Douglas Ferguson
Regulation Number880.5730
Classification Product Code
QFG  
Date Received01/02/2026
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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