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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Drug Dose
510(k) Number K260910
Device Name EndoTool IV Cloud 1.0
Applicant
Glooko, Inc.
579 University Ave.
Palo Alto,  CA  94301
Applicant Contact Katherine Rojas
Correspondent
Glooko, Inc.
579 University Ave.
Palo Alto,  CA  94301
Correspondent Contact Katherine Rojas
Regulation Number868.1890
Classification Product Code
NDC  
Date Received03/19/2026
Decision Date 05/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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