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Hemodialysate Solutions

by Bicarbolyte Corp.

510(k) K843866

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 NumberK843866 Date9 Jan 1985ClearedStatusActive

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  • Withdrawn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, 27 Sep 2026

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

Hemodialysate Solutions are dialysate concentrates for hemodialysis provided in either liquid or powder form. These solutions are used to facilitate the hemodialysis process.

This device is identified under FDA 510(k) number K843866 and is regulated under 21 CFR 876.5820. It is manufactured by Bicarbolyte Corp.

Other devices from Bicarbolyte Corp.

Questions

AI-generated answers, 27 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 are Hemodialysate Solutions used for?

    These solutions are used to facilitate the hemodialysis process. They serve as the dialysate concentrate required to perform hemodialysis treatments.

  • In what forms are these hemodialysis concentrates supplied?

    Bicarbolyte Corp. provides these Hemodialysate Solutions in either liquid or powder form to accommodate different clinical requirements for the hemodialysis process.

  • What is the regulatory status of this device?

    This device is identified under FDA 510(k) number K843866 and is regulated under 21 CFR 876.5820, which classifies it as a dialysate concentrate for hemodialysis.