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NxStage System One

by NxStage Medical, Inc. EUDAMED510(k)GUDID

Withdrawn No longer placed on the EU market

Ref NX1000-3-A

Overview

The NxStage System One is an ultrafiltration-controlled nocturnal dialysate delivery system. This device is designed to facilitate dialysate delivery and ultrafiltration processes for patients requiring renal support therapy.

The system is identified by model number NX1000-3-A and is manufactured by NxStage Medical, Inc. It is not an implantable device and is not supplied in a sterile state.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-M535NX10003A0 Basic UDI-DIDate30 Apr 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesFDA 510(k) 510(k) NumberK171331 Date24 Aug 2017IssuedStatusActive
United StatesGUDID listing GUDID NumberM535NX10003A0 UDI-DIDate1 Sep 2015ListedStatusWithdrawn

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Withdrawn

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

5 recalls · FDA

    • Terminated Z-0697-2020 FDA Class II initiated 27 Aug 2019 via K050525, on the same 510(k)

    There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) when prescribing larger dialysate volumes.

  • 3 recalls, same reason

    • Terminated Z-0336-2016 FDA Class II initiated 29 Oct 2015
    • Terminated Z-0337-2016 FDA Class II initiated 29 Oct 2015
    • Terminated Z-0335-2016 FDA Class II initiated 29 Oct 2015

    Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed

    • Terminated Z-1228-2007 FDA Unclassified (pre-2012) initiated 27 Jul 2007

    Potential for dialysate leaks from the cartridge during treatment.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Haemodialysis system, institutional/home-use
Model / Reference
NX1000-3-A
Primary DI / UDI-DI
M535NX10003A0
Basic UDI-DI
B-M535NX10003A0
FDA Product Code
KDI
EMDN Code
F9099 Dialysis devices - other
GMDN Term
Haemodialysis system, institutional/home-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.5860
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000026832
Authorised representative
Fresenius Medical Care Deutschland GmbH DE-AR-000009269

Other devices from NxStage Medical, Inc.

See all devices from NxStage Medical, Inc. →

Questions

  • What is the primary function of the NxStage System One?

    The NxStage System One is an ultrafiltration-controlled nocturnal dialysate delivery system, which is used to manage fluid and solute removal during dialysis treatments.

  • Is the NxStage System One an implantable device?

    No, the NxStage System One is not an implantable device; it is an external medical system used for dialysate delivery.

  • What is the model number for this specific device?

    The specific model number for this device is NX1000-3-A, as identified in the manufacturer's product specifications.

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No