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Dri-Sate Dry Acid Concentrate For Bicarbonate Dialysate

by Rockwell Medical Technologies, Inc.

510(k) K022500

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

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 NumberK022500 Date23 Dec 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

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  • Withdrawn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, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Dri-Sate Dry Acid Concentrate for Bicarbonate Dialysate is a dialysate concentrate for hemodialysis in powder form. It is formulated for use in acute and chronic hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate or powder.

This device is supplied as a powder containing salt, sugar, and non-sugar components for use in a three-stream dialysis system. It is regulated under FDA 510(k) number K022500 and is classified as a class 2 medical device.

Other devices from Rockwell Medical Technologies, Inc.

Questions

AI-generated answers, 6 Oct 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 intended use of Dri-Sate Dry Acid Concentrate?

    Dri-Sate is a dialysate concentrate in powder form designed for use in hemodialysis procedures. It is specifically formulated for both acute and chronic hemodialysis applications.

  • How is the dialysate prepared for use?

    The product is designed for use in a three-stream dialysis system. To prepare the dialysate, the powder must be mixed or proportioned with the appropriate volume of purified water and a bicarbonate concentrate or powder.

  • What is the composition and regulatory status of this device?

    Dri-Sate is supplied as a powder containing a mixture of salt, sugar, and non-sugar components. It is classified as a class 2 medical device and is regulated under FDA 510(k) number K022500.