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Art Bicarbonate for Hemodialysis

by Advanced Renal Technologies, Inc.

510(k) K010760

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 NumberK010760 Date11 Jun 2001ClearedStatusActive

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  • Withdrawn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
Art Bicarbonate for Hemodialysis, Art Bicarbonate Liquid for Hemodialysis
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, 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.

Art Bicarbonate for Hemodialysis is a liquid formulation used during hemodialysis to help maintain the acid-base balance in patients with renal failure. It is designed to correct the composition of uremic blood to physiological levels.

This device is supplied as a liquid dialysate concentrate for hemodialysis and is regulated under FDA 510(k) clearance K010760. It is manufactured by Advanced Renal Technologies, Inc. and is classified as a dialysate concentrate for hemodialysis (liquid or powder).

Other devices from Advanced Renal Technologies, Inc.

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 ART Bicarbonate for Hemodialysis used for?

    ART Bicarbonate for Hemodialysis is a liquid formulation used during hemodialysis to help maintain the acid-base balance in patients with renal failure. It is designed to correct the composition of uremic blood to physiological levels.

  • How is ART Bicarbonate for Hemodialysis supplied?

    This device is supplied as a liquid dialysate concentrate specifically formulated for hemodialysis procedures. It comes ready-to-use in its liquid form for clinical application.

  • What is the regulatory status of ART Bicarbonate for Hemodialysis?

    ART Bicarbonate for Hemodialysis is regulated under FDA 510(k) clearance K010760 and is classified as a dialysate concentrate for hemodialysis (liquid or powder). It received traditional clearance with a decision code of SESE, indicating substantial equivalence.

  • Who manufactures ART Bicarbonate for Hemodialysis?

    ART Bicarbonate for Hemodialysis is manufactured by Advanced Renal Technologies, Inc., located in Kirkland, Washington. The company specializes in developing renal care products for clinical use.