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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemodialyzer With Expanded Solute Removal Profile
510(k) Number K261399
Device Name ELISIO™-HX
Applicant
Nipro Medical Corporation
3150 NW 107th Ave.
Miami,  FL  33172
Applicant Contact Jessica Oswald-McLeod
Correspondent
Nipro Medical Corporation
3150 NW 107th Ave.
Miami,  FL  33172
Correspondent Contact Jessica Oswald-McLeod
Regulation Number876.5862
Classification Product Code
QAX  
Date Received04/29/2026
Decision Date 07/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT07058909
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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