Dialysate Meter RS-2100A Circuit Change

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K770263 ↗

FDA Product Code

FLB

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 Renal Systems, Inc. →

• What is the primary function of the Dialysate Meter RS-2100A?

  The RS-2100A is an induction-type conductivity meter designed for remote monitoring. It serves as a specialized component within a hemodialysis system, which acts as an artificial kidney to treat patients suffering from renal failure or toxemic conditions.

• Under what regulatory framework is this device categorized?

  The device is regulated under 21 CFR 876.5820 and is identified by the product code FLB. It received FDA 510(k) clearance under K770263, confirming it is substantially equivalent to other devices in its class.

• What medical specialty oversees the use of this meter?

  The Dialysate Meter RS-2100A is categorized under the Gastroenterology and Urology medical specialties, as it is a component used in hemodialysis systems for renal treatment.