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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 K250523
Device Name Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)
Applicant
Simergent, LLC
11 NE 11th St. Suite 229
Oklahoma City,  OK  73104
Applicant Contact Steve Lindo
Correspondent
Simergent, LLC
11 NE 11th St. Suite 229
Oklahoma City,  OK  73104
Correspondent Contact Steve Lindo
Regulation Number876.5630
Classification Product Code
FKX  
Date Received02/21/2025
Decision Date 10/02/2025
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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