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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K261530
Device Name iiSure Infusion Set
Applicant
Deka Research and Development
340 Commercial St.
Manchester,  NH  03101
Applicant Contact Paul Smolenski
Correspondent
Deka Research and Development
340 Commercial St.
Manchester,  NH  03101
Correspondent Contact Paul Smolenski
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/08/2026
Decision Date 06/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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