Hemodialysis Bath

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K922990 ↗

FDA Product Code

KPO

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Medi-Tech, Inc. →

• What is the Hemodialysis Bath used for?

  The Hemodialysis Bath is used to prepare the dialysate, a solution that helps remove waste products from the blood during hemodialysis, a medical treatment that filters and purifies the blood using a dialyzer.

• Is the Hemodialysis Bath supplied sterile?

  The description does not specify if the Hemodialysis Bath is supplied sterile, but it is intended for use in a medical setting, such as a hospital or dialysis clinic, where sterility is typically maintained.

• What is the regulatory classification of the Hemodialysis Bath?

  The Hemodialysis Bath is classified as a Dialysate Concentrate For Hemodialysis device, with a product code of KPO, and is regulated under regulation number 876.5820.

• Who is the manufacturer of the Hemodialysis Bath?

  The Hemodialysis Bath is manufactured by Medi-Tech, Inc.