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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 K260429
Device Name Control-IQ+ technology
Applicant
Tandem Diabetes Care, Inc.
12400 High Bluff Dr.
San Diego,  CA  92130
Applicant Contact Amulya Mallavarapu
Correspondent
Tandem Diabetes Care, Inc.
12400 High Bluff Dr.
San Diego,  CA  92130
Correspondent Contact Geena George
Regulation Number862.1356
Classification Product Code
QJI  
Date Received02/10/2026
Decision Date 04/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Clinical Trials NCT04902378
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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