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Bicarbonate Dialysate Concentrate Mixer, Model 50 Gallon & 100 Gallon

by Rockwell Medical Technologies, Inc.

510(k) K022521

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022521 Date3 Jan 2003ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0439-2009 FDA Unclassified (pre-2012) initiated 29 Sep 2008
    • Terminated Z-0440-2009 FDA Unclassified (pre-2012) initiated 29 Sep 2008

    Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.

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  • Withdrawn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
KPO
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Dialysate Concentrate for Hemodialysis (Liquid or Powder), designed to prepare bicarbonate-based dialysate solutions for hemodialysis procedures. It combines dry concentrate powders with water to create a sterile dialysate solution, facilitating the removal of waste and excess fluids from a patient’s blood during dialysis. The mixer ensures precise formulation of bicarbonate-containing dialysate, which is critical for maintaining electrolyte balance and acid-base equilibrium in patients undergoing hemodialysis.

The Bicarbonate Dialysate Concentrate Mixer is supplied as a reusable system in two tank sizes—50-gallon and 100-gallon models—intended for use in clinical hemodialysis settings. It is regulated under FDA 510(k) clearance (K022521) as a Class II device, adhering to regulatory standards for hemodialysis equipment. The device requires proper storage, handling, and maintenance to ensure sterility and functionality, with no specific MRI safety considerations noted. Authorized for use in acute and chronic hemodialysis, it operates under the regulatory framework outlined in 21 CFR 876.5820.

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