Skip to content

NxStage Cartridge Express with Speedswap

by NxStage Medical, Inc.

510(k) K183158

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183158↗

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 NumberK183158 Date9 Aug 2019ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1191-2024 FDA Class II initiated 29 Jan 2024

    Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare professional could be exposed to infectious patient blood.

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  • Withdrawn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.

This device is a High Permeability Dialyzer with or without a Sealed Dialysate System, designed for use in hemodialysis therapy. It facilitates efficient removal of waste products and excess fluids from the blood of patients with acute or chronic renal failure, leveraging high-permeability membranes to enhance clearance rates.

The Cartridge Express with Speedswap is an optional accessory intended for use exclusively with the NxStage System One. It enables rapid replacement of a flow-compromised filter without full cartridge replacement, reducing downtime during therapy. Supplied as a single-use, sterile device, it requires no additional sterilization and is regulated under FDA 510(k) clearance and the EU Medical Device Directive (MDD). The device is classified as a Class II medical device under CFR Title 21, Regulation Number 876.5860.

Other devices from NxStage Medical, Inc.

See all devices from NxStage Medical, Inc. →

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 is the primary purpose of the NxStage Cartridge Express with Speedswap, and how does it differ from a standard dialyzer?

    The NxStage Cartridge Express with Speedswap is designed as a High Permeability Dialyzer to efficiently remove waste products and excess fluids during hemodialysis for patients with acute or chronic renal failure. Unlike standard dialyzers, this accessory is specifically engineered for the NxStage System One and allows for rapid replacement of a flow-compromised filter without requiring a full cartridge swap. This reduces downtime during therapy, making it ideal for situations where a filter may become clogged or compromised mid-treatment.

  • Is the NxStage Cartridge Express with Speedswap single-use or reusable, and what does that mean for sterilization?

    The device is supplied as a single-use, sterile product, meaning it is intended for one-time use only and does not require additional sterilization before or after use. This design ensures patient safety by eliminating the risk of contamination from reuse, as well as simplifying handling and disposal protocols for clinical staff.

  • How is the NxStage Cartridge Express with Speedswap regulated, and what does that imply for its use in clinical settings?

    The device holds FDA 510(k) clearance and complies with the EU Medical Device Directive (MDD), confirming it meets regulatory standards for safety and performance. It is classified as a Class II medical device under CFR Title 21, Regulation Number 876.5860, which means it undergoes rigorous review to ensure its intended use—rapid filter replacement in hemodialysis—is both effective and safe. Clinicians can rely on its regulatory approval to support its integration into dialysis protocols.

  • What systems or machines is the NxStage Cartridge Express with Speedswap compatible with, and how does that affect its deployment?

    This cartridge is exclusively designed for use with the NxStage System One, a specific hemodialysis machine. Its compatibility is limited to this system, meaning it cannot be used with other dialysis machines. Clinicians must ensure the NxStage System One is available when deploying this accessory to maintain seamless therapy continuity, particularly when addressing flow-compromised filters during treatment.