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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Insulin
510(k) Number K253534
Device Name Pivot Insulin Delivery System
Applicant
Modular Medical
10740 Thornmint Rd.
San Diego,  CA  92127
Applicant Contact Shahzaib Rai
Correspondent
Modular Medical
10740 Thornmint Rd.
San Diego,  CA  92127
Correspondent Contact Kelsie DiPerna
Regulation Number880.5725
Classification Product Code
LZG  
Date Received11/13/2025
Decision Date 04/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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