Medical Device Manufacturer · US , Oklahoma City , OK

Simergent, LLC

1 submissions · 1 cleared · Since 2025

Total

Cleared

Denied

Simergent, LLC — FDA 510(k) Submissions

Simergent, LLC has submitted 1 FDA 510(k) premarket notifications since 2025, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Peritoneal, Automatic Delivery . Use the specialty filter in the sidebar to narrow results.

1 devices

1–1 of 1

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)

K250523 · FKX System, Peritoneal,... · Gastroenterology & Urology

Oct 2025 223d

Simergent, LLC

Simergent, LLC — FDA 510(k) Submissions

Filters