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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 K253281
Device Name UpDoc
Applicant
Updoc, Inc.
851 Sierra Vista Ave., Unit A
Mountain View,  CA  94043
Applicant Contact Kendal Dinsmore
Correspondent
RQM+
2790 Mosside Blvd.
#800
Monroeville,  PA  15146
Correspondent Contact Erin Gontang
Regulation Number868.1890
Classification Product Code
NDC  
Date Received09/29/2025
Decision Date 12/23/2025
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		 Yes
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