# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Simergent, LLC
- Decided: Oct 2, 2025 after 223 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K822549 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002892: Frsenius PD Iqcard Cycler, Fresenius Medical Care North America (2001) Summary page 5.
- K822549: CCPD Cycler Set W/5 Pronged Safe Lock, American Medical Products, Inc. (1982) Summary page 5.

## Indications for use
The Archimedes APD system is an Automated Peritoneal Dialysis system indicated for acute and chronic peritoneal dialysis for adult patients in clinical and home use. A care partner is not required. The following therapies are supported: Continuous Cyclic Peritoneal Dialysis (CCPD) and Intermittent Peritoneal Dialysis (IPD). Mid-day exchanges are not supported.

Source page: https://510kreport.com/device/K250523
Methodology: https://510kreport.com/methodology