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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K251745
Device Name Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
Applicant
Baxter Healthcare Corporation
One Baxter Pkwy.
Deerfield Lake,  IL  60015
Applicant Contact Aravinda Yellina
Correspondent
Baxter Healthcare Corporation
One Baxter Pkwy.
Deerfield Lake,  IL  60015
Correspondent Contact Aravinda Yellina
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received06/06/2025
Decision Date 12/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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