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)
510(k) K250523
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250523 | Date2 Oct 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FKX
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5630
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Archimedes Pro and Standard Automated Peritoneal Dialysis Cyclers are systems designed for automatic delivery of peritoneal dialysis therapy. The device is classified as a System, Peritoneal, Automatic Delivery under FDA product code FKX and regulation number 876.5630. It includes the cycler unit and associated disposable tubing sets for Pro, Standard, and Pro Plus configurations.
The device received FDA 510(k) clearance (K250523) on October 2, 2025, as substantially equivalent to a predicate device. It is intended for use in home peritoneal dialysis settings. The disposable tubing sets are supplied sterile and are for single-use only. The cycler is a reusable device. No MRI safety information is provided in the data.
Other devices from Simergent, LLC
Questions
AI-generated answers, 22 Sep 2026
What is the Archimedes Pro Automated Peritoneal Dialysis Cycler used for?
The Archimedes Pro and Standard Automated Peritoneal Dialysis Cyclers are systems designed for automatic delivery of peritoneal dialysis therapy, intended for use in home peritoneal dialysis settings to automate the fill, dwell, and drain cycles of treatment.
Are the disposable tubing sets for the Archimedes cycler sterile and single-use?
Yes, the disposable tubing sets for the Archimedes Pro, Standard, and Pro Plus configurations are supplied sterile and are designated for single-use only, as specified in the device description, to prevent cross-contamination and ensure patient safety during each dialysis session.
Is the Archimedes cycler unit reusable or disposable?
The Archimedes Pro and Standard Automated Peritoneal Dialysis Cyclers are reusable devices, while the associated disposable tubing sets (Pro, Standard, and Pro Plus) are single-use only, meaning the cycler unit can be used for multiple treatments with new tubing sets each time.
What models or configurations are available for the Archimedes peritoneal dialysis system?
The Archimedes system includes the Archimedes Pro Automated Peritoneal Dialysis Cycler (model 3014-00000-1), the Archimedes Standard Automated Peritoneal Dialysis Cycler (model 3014-00000-3), and three disposable tubing sets: Archimedes Pro Disposable Tubing Set (3014-50000-1), Archimedes Standard Disposable Tubing Set (3014-50000-3), and Archimedes Pro Plus Disposable Tubing Set (3014-50000-5).
What regulatory pathway was used for the Archimedes cycler’s market authorization?
The Archimedes Pro and Standard Automated Peritoneal Dialysis Cyclers received FDA 510(k) clearance (K250523) on October 2, 2025, as substantially equivalent to a predicate device, which is the regulatory pathway indicated in the device data under AUTHORIZATIONS and decision_description.