Cleared Traditional

K250523 - Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1) (FDA 510(k) Clearance)

Also includes:

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)

K250523 · Simergent, LLC · Gastroenterology & Urology device

Oct 2025

Decision

223d

Days

Class 2

Risk

K250523 is an FDA 510(k) clearance for the Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1). This device is classified as a System, Peritoneal, Automatic Delivery (Class II - Special Controls, product code FKX).

Submitted by Simergent, LLC (Oklahoma City, US). The FDA issued a Cleared decision on October 2, 2025, 223 days after receiving the submission on February 21, 2025.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number	K250523 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 21, 2025
Decision Date	October 02, 2025
Days to Decision	223 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF