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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K254074
Device Name TruPress
Applicant
Procerus Enterprises
2505 E. 3300 S
Suite 202
Salt Lake City,  UT  84124
Applicant Contact Jordan Cox
Correspondent
Ontogen Medtech
815 Ogden Ave.
Lisle,  IL  60532
Correspondent Contact Julie Byars
Regulation Number870.2850
Classification Product Code
DRS  
Date Received12/18/2025
Decision Date 09/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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