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Optiflux F250NR, Model 0500325E

by Fresenius Medical Care North America

510(k) K082414

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK082414 Date28 Oct 2008ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1105-2014 FDA Class II initiated 4 Feb 2014

    Dialysate Port Leak During Priming of the Dialyzers

    • Terminated Z-0825-2012 FDA Unclassified (pre-2012) initiated 27 Dec 2011

    Optiflux F250NRe Hemodialyzers have increased risk of an internal blood leak

    • Terminated Z-1622-2011 FDA Unclassified (pre-2012) initiated 16 Feb 2011

    There is an increased risk of an internal blood leak.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 26 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 Optiflux F250NR, Model 0500325E is a high permeability dialyzer. It is designed to facilitate the removal of waste products and excess fluid from the blood during dialysis procedures.

This device is supplied by Fresenius Medical Care North America and is regulated under FDA 510K authorization. It is classified as a class 2 medical device intended for use in clinical settings.

Other devices from Fresenius Medical Care North America

See all devices from Fresenius Medical Care North America →

Questions

AI-generated answers, 26 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 function of the Optiflux F250NR?

    The Optiflux F250NR is a high permeability dialyzer intended to facilitate the removal of waste products and excess fluid from a patient's blood during dialysis procedures.

  • In what environment is this device intended to be used?

    This device is classified as a class 2 medical device and is intended for use specifically in clinical settings.

  • What is the regulatory status of this dialyzer?

    The Optiflux F250NR, Model 0500325E, is regulated under FDA 510K authorization, which indicates it has been cleared for market based on its substantial equivalence to other legally marketed devices.