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DMS 3000 Dialysate Delivery System

by Renal Care Corp.

510(k) K792252

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 NumberK792252 Date12 Mar 1980ClearedStatusActive

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  • Withdrawn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)

Full name
Dms 3000
510(k) Number
FDA Product Code
FKQ
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The DMS 3000 is a Central Multiple Patient Dialysate Delivery System (Product Code: FKQ), designed for hemodialysis. It provides controlled delivery of dialysate fluid to multiple patients simultaneously, facilitating renal replacement therapy in clinical settings. This system is intended for use in conjunction with an extracorporeal blood circuit and conventional dialyzer to manage renal failure or toxemic conditions.

The device is supplied as a reusable medical system, intended for use in dialysis centers under sterile conditions. It is classified as a Class II device under FDA regulations (21 CFR 876.5820) and holds a FDA 510(k) clearance (K792252) with a decision of Substantially Equivalent. Multiple registration numbers (e.g., 3004201412, 3004176176) reflect its compliance with U.S. regulatory requirements for hemodialysis support systems.

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Questions

AI-generated answers, 1 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 DMS 3000 used for?

    The DMS 3000 is a Central Multiple Patient Dialysate Delivery System designed specifically for hemodialysis. It provides controlled, simultaneous delivery of dialysate fluid to multiple patients, working alongside an extracorporeal blood circuit and conventional dialyzer to manage renal failure or toxemic conditions in clinical dialysis centers.

  • Is the DMS 3000 reusable or single-use?

    The DMS 3000 is supplied as a reusable medical system. It is intended for use in dialysis centers under sterile conditions, ensuring repeated applications across multiple patients while maintaining regulatory compliance for hemodialysis support.

  • What regulatory approvals does the DMS 3000 hold?

    The DMS 3000 holds FDA 510(k) clearance (K792252) with a decision of Substantially Equivalent. It is classified as a Class II device under FDA regulations (21 CFR 876.5820) and complies with multiple U.S. registration numbers, including 3004201412 and 3004176176.

  • How is the DMS 3000 supplied and prepared for use?

    The system is supplied as a reusable medical device, intended for use in sterile conditions within dialysis centers. It requires proper setup and maintenance to ensure sterile delivery of dialysate to patients, adhering to clinical protocols for hemodialysis.

  • What are the key specifications or models associated with the DMS 3000?

    The DMS 3000 operates under the FDA product code FKQ for Central Multiple Patient Dialysate Delivery Systems. It is associated with several registration numbers (e.g., 3004201412, 3004176176) and falls under the medical specialty descriptions of Gastroenterology and Urology, reflecting its role in renal replacement therapy.