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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Peritoneal, Automatic Delivery
510(k) Number K243371
Device Name Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
Applicant
Byonyks Pvt, Ltd.
45/A Xx Block Khayban-E-Iqbal
Phase Iii Dha
Lahore,  PK 54000
Applicant Contact Eric Flachbart
Correspondent
Byonyks Pvt, Ltd.
45/A Xx Block Khayban-E-Iqbal
Phase Iii Dha
Lahore,  PK 54000
Correspondent Contact Eric Flachbart
Regulation Number876.5630
Classification Product Code
FKX  
Subsequent Product Code
KDJ  
Date Received10/30/2024
Decision Date 05/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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