NXStage System One with Cartridge Express
510(k) K032356
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK032356 | Date28 Oct 2003 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- KDI
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5860
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The NXStage System One with Cartridge Express is a high-permeability dialyzer with or without a sealed dialysate system, designed for hemodialysis. It facilitates the removal of waste products and excess fluids from the blood of patients with end-stage renal disease, utilizing a semipermeable membrane to filter blood during treatment sessions.
This device is supplied as a single-use, sterile system intended for use in clinical settings such as dialysis centers. It operates within Class II regulatory classification under FDA 510(k) clearance and MDD authorization, adhering to strict sterility and safety standards. The system includes multiple cartridge variants, each identified by unique reference codes, and requires proper storage in accordance with manufacturer guidelines to maintain efficacy and safety.
Other devices from NxStage Medical, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the NXStage System One with Cartridge Express in clinical settings?
The NXStage System One with Cartridge Express is designed specifically for hemodialysis, a process that removes waste products and excess fluids from the blood of patients with end-stage renal disease. It uses a semipermeable membrane to filter blood during treatment sessions, ensuring efficient clearance of toxins and fluid overload.
Is the NXStage System One with Cartridge Express intended for single-use or reusable applications?
The device is explicitly supplied as a single-use, sterile system, meaning each cartridge is intended for one treatment session only. This design ensures patient safety and sterility, as reuse is not recommended or supported by the manufacturer.
How many cartridge variants are available for the NXStage System One, and how are they identified?
The system includes multiple cartridge variants, each distinguished by unique reference codes listed in the regulatory data (e.g., 3033903155, 3002806443, etc.). These codes help clinicians and facilities select the appropriate cartridge for their patient’s specific hemodialysis needs.
What storage requirements must be followed to maintain the efficacy and safety of the NXStage System One with Cartridge Express?
The manufacturer specifies that the system must be stored in accordance with their guidelines to preserve sterility and functionality. While exact storage conditions (e.g., temperature, humidity) aren’t detailed here, adherence to the provided instructions is critical to ensure the device remains safe and effective for its intended single-use application.
What regulatory pathways does the NXStage System One with Cartridge Express follow, and how does this affect its use?
The device has received FDA 510(k) clearance and MDD authorization, confirming it meets regulatory standards for high-permeability dialyzers with or without sealed dialysate systems. This classification under Class II ensures it undergoes rigorous review for safety and performance, but it does not imply any specific clinical indication—only that it adheres to established regulatory requirements for hemodialysis devices.