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Biasol Concentrates For Bicarbonate Dialysis

by Baxter Healthcare Corp

510(k) K880102

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 NumberK880102 Date26 May 1988ClearedStatusActive

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  • Withdrawn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, 24 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 Biasol Concentrates For Bicarbonate Dialysis is a dialysate concentrate for hemodialysis, classified as a liquid or powder. It is used in hemodialysis procedures. The device is a concentrate for bicarbonate dialysis.

The device is supplied by Baxter Healthcare Corp and has an FDA 510K clearance with the number K880102. It is classified as a Class II device with special controls, and its regulation number is 876.5820. The device is used in the medical specialties of Gastroenterology and Urology.

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Questions

AI-generated answers, 24 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 Biasol Concentrates For Bicarbonate Dialysis used for?

    The Biasol Concentrates For Bicarbonate Dialysis is used in hemodialysis procedures, specifically for bicarbonate dialysis, in the medical specialties of Gastroenterology and Urology.

  • What is the regulatory status of the device?

    The device has an FDA 510K clearance with the number K880102 and is classified as a Class II device with special controls, under regulation number 876.5820.

  • Who is the manufacturer of the Biasol Concentrates For Bicarbonate Dialysis?

    The device is supplied by Baxter Healthcare Corp, with a contact person of ROBERT L WILKINSON, and is located in Round Lake, IL, US.

  • What type of device is the Biasol Concentrates For Bicarbonate Dialysis?

    The device is a dialysate concentrate for hemodialysis, classified as a liquid or powder.