K250523
- 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 OK · US
- Product code
- FKX — System, Peritoneal, Automatic Delivery
- Decision date
- 2025-10-02
- Date received
- 2025-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250523.pdf
Official FDA record: K250523
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.