Data / Medical devices / United States / Simergent, LLC
Simergent, LLC: FDA-registered device maker in Oklahoma City, OK, United States, 1 510(k) clearance
Simergent, LLC is registered with the FDA (registration 3025094646) in Oklahoma City, OK, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025094646
- Address
- 11 NE 11th St Suite 229, Oklahoma City, OK, United States, 73104
- Owner or operator
- Simergent, LLC (10096032)
- Roles
- Manufacturer
- First device listed
- June 10, 2026
- Registered through
- 2026
- Brand names listed
- Archimedes Pro Automated Peritoneal Dialysis Cycler, Archimedes Pro Disposable Tubing Set, Archimedes Pro Plus Disposable Tubing Set, Archimedes Standard Automated Peritoneal Dialysis Cycler, Archimedes Standard Disposable Tubing Set
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Peritoneal, Automatic Delivery | FKX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 2, 2025 | K250523 | 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) | FKX | Substantially Equivalent | Simergent, LLC | accessdata.fda.gov |
Compare with other makers
Updated October 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.