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NxStage System One Low Volume Cartridge Express

by NxStage Medical, Inc.

510(k) K123395

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123395↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK123395 Date7 Mar 2013ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The NxStage System One Low Volume Cartridge Express is a High Permeability Dialyzer with or without a sealed dialysate system, designed for use in hemofiltration, hemodialysis, and ultrafiltration. It is intended for single-patient use in the treatment of acute and chronic renal failure or fluid overload by removing waste products and excess fluids from the bloodstream through a semipermeable membrane.

This cartridge is supplied as a single-use, sterile disposable component for use exclusively with the NxStage System One device in chronic care dialysis facilities or acute care units. It is classified as a Class II medical device under FDA regulations (21 CFR 876.5860) and has received FDA 510(k) clearance and MDD authorization. The cartridge is non-magnetic and intended for use in non-MRI environments. No additional sterilization or reprocessing is required beyond manufacturer-provided instructions.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of dialysis treatments is the NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS designed for, and how does it differ from standard dialyzers?

    The NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS is specifically designed for hemofiltration, hemodialysis, and ultrafiltration, making it versatile for both acute and chronic renal failure or fluid overload management. Unlike standard dialyzers, it features a high permeability membrane, which enhances the efficiency of waste and fluid removal from the bloodstream. It is also supplied as a sealed dialysate system option, ensuring convenience and reducing the risk of contamination during use.

  • Is this cartridge reusable, or is it intended for single-use only? What does that mean for my facility’s workflow?

    This cartridge is intended for single-patient use only, meaning it cannot be reused or reprocessed after one treatment. This design eliminates the need for additional sterilization or cleaning steps beyond what the manufacturer provides, simplifying workflows in both chronic care dialysis facilities and acute care units. Single-use also reduces the risk of cross-contamination, ensuring patient safety.

  • Are there different sizes or models available for this cartridge, and how do I determine which one to use?

    The provided data does not specify individual sizes or models beyond the NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS designation. However, it is exclusively compatible with the NxStage System One device, so selection is based on the treatment protocol and patient needs (e.g., acute vs. chronic renal failure). Facilities should consult the manufacturer’s guidelines or technical specifications to confirm compatibility and proper sizing for their patients.

  • How should the cartridge be stored, and what precautions should be taken to maintain its sterility?

    Since the cartridge is sterile and single-use, it must be stored in its original, unopened packaging to preserve sterility. The manufacturer’s instructions should specify storage conditions (e.g., temperature, humidity, and protection from light), but generally, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposing it to moisture or contamination before use.

  • Can this cartridge be used in an MRI environment, or are there any special considerations for its use?

    The cartridge is explicitly non-magnetic and not intended for use in MRI environments. If a patient requires MRI imaging, the cartridge must be removed from the NxStage System One device beforehand, as MRI machines generate strong magnetic fields that could pose risks to non-MRI-compatible medical devices. Always follow facility protocols for MRI-safe equipment handling.