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Allient Sorbent Hemodialysis System, Model 1000

by Renal Solutions, Inc.

510(k) K043574

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 NumberK043574 Date3 Jun 2005ClearedStatusActive

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  • Withdrawn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
FKT
Device Class
Class II
Regulation
21 CFR Part 876.5600
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Allient Sorbent Hemodialysis System, Model 1000 is a sorbent regenerated dialysate delivery system for hemodialysis. It is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and consists of a sorbent cartridge and the means to circulate dialysate through this cartridge and the dialysate compartment of the dialyzer.

The device is manufactured by Renal Solutions, Inc. and was cleared by the FDA through the 510(k) pathway on June 3, 2005. It is classified as a Class 2 medical device under product code FKT and regulation number 876.5600, with medical specialty description in Gastroenterology and Urology.

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Questions

AI-generated answers, 28 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 Allient Sorbent Hemodialysis System Model 1000 used for?

    The Allient Sorbent Hemodialysis System Model 1000 is used for hemodialysis treatment of patients with renal failure or toxemic conditions by delivering regenerated dialysate through a sorbent cartridge and the dialysate compartment of the dialyzer as part of an artificial kidney system.

  • How is the Allient Sorbent Hemodialysis System Model 1000 supplied or configured for use?

    The system consists of a sorbent cartridge and the means to circulate dialysate through this cartridge and the dialysate compartment of the dialyzer, forming a sorbent regenerated dialysate delivery system for hemodialysis.

  • What regulatory pathway was used for the Allient Sorbent Hemodialysis System Model 1000?

    The device was cleared by the FDA through the 510(k) pathway on June 3, 2005, under submission number K043574, and is classified as a Class 2 medical device under product code FKT and regulation number 876.5600.