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NxStage Cartridge Express Modification

by NxStage Medical, Inc.

510(k) K050727

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) K050727↗

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 · Special NumberK050727 Date13 Jun 2005ClearedStatusActive
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  • Withdrawn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)

Full name
Modification to Nxstage Cartridge Express
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 Dialyzer, High Permeability With or Without Sealed Dialysate System, designed for hemodialysis treatment. It functions as a semipermeable membrane cartridge that facilitates the exchange of solutes and fluids between the patient’s blood and the dialysate, effectively removing waste products and excess fluids during renal replacement therapy.

The NxStage Cartridge Express Modification is intended for single-use in home hemodialysis systems. It is classified under FDA regulation 876.5860 and received FDA 510(k) clearance (K050727) as a Substantially Equivalent modification to the original design. Supplied sterile and intended for use in medical facilities or home settings, it adheres to regulatory standards for high-permeability dialyzers, with no indication of MRI compatibility or reusable components.

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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 is the primary purpose of the NxStage Cartridge Express Modification in hemodialysis treatment?

    The NxStage Cartridge Express Modification is designed as a high-permeability dialyzer for hemodialysis, functioning as a semipermeable membrane cartridge. Its purpose is to facilitate the exchange of solutes and fluids between the patient’s blood and dialysate, effectively removing waste products and excess fluids during renal replacement therapy. It is specifically intended for use in home hemodialysis systems.

  • Is the NxStage Cartridge Express Modification intended for reuse or is it single-use only?

    The NxStage Cartridge Express Modification is explicitly intended for single-use only, as stated in the device description. This ensures patient safety and sterility, as it is supplied sterile and designed for use in either medical facilities or home settings without any indication of reusable components.

  • How is the NxStage Cartridge Express Modification supplied, and what does this imply for its handling?

    The device is supplied sterile, which implies it is pre-sterilized and packaged to maintain sterility until use. This means it should be handled with care to avoid contamination, and any unopened packaging should be stored properly to preserve its sterile condition. The single-use nature also means it should not be reused after a single hemodialysis session.

  • What regulatory pathway was followed for the clearance of this modification, and what does this mean for its use?

    The NxStage Cartridge Express Modification received FDA 510(k) clearance (K050727) as a substantially equivalent modification to the original design, classified under FDA regulation 876.5860. This means the device was evaluated and determined to be as safe and effective as legally marketed alternatives, allowing it to be legally marketed and used in the United States for its intended purpose in hemodialysis.

  • Are there any specific storage requirements or considerations for the NxStage Cartridge Express Modification?

    While the provided data does not specify exact storage conditions, the device is supplied sterile and intended for single-use. Generally, such dialyzers should be stored in a clean, dry environment, protected from extreme temperatures, direct sunlight, and physical damage. Always follow manufacturer guidelines for optimal storage to maintain sterility and functionality until use.