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Acid Concentrate 45x (2.0k, 3.1ca) (5m8001a +3 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090002

by Baxter Healthcare Corp

Identifiers

510(k) Number
K090002 FDA 510(k)
FDA Product Code
KPO FDA 510(k)
Models / Variants
5m8001a FDA 510(k)
Acid Concentrate 45x (2.0k FDA 510(k)
2.5ca) FDA 510(k)
Model 5m8002a FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5820 FDA 510(k)
Regulation Number
876.5820 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Acid Concentrate 45x is a dialysate concentrate for hemodialysis, available in liquid or powder form. It functions as a component in hemodialysis therapy by being mixed and proportioned with a bicarbonate concentrate solution and purified water in a three-stream hemodialysis machine.

This device is supplied by Baxter Healthcare Corp and has received FDA 510k clearance. It is classified as an FDA class 2 device under regulation number 876.5820. The product is available in two specific formulations identified by model numbers 5M8001A and 5M8002A.

Frequently asked questions

What is the intended use of the Acid Concentrate 45x?

This device is a dialysate concentrate used in hemodialysis therapy. It functions by being mixed and proportioned with a bicarbonate concentrate solution and purified water within a three-stream hemodialysis machine to create the final dialysate.

What are the available model variations for this concentrate?

The product is available in two specific formulations identified by model numbers 5M8001A and 5M8002A. These models differ in their specific chemical concentrations, specifically 2.0K, 3.1CA for model 5M8001A and 2.0K, 2.5CA for model 5M8002A.

In what physical forms is the dialysate concentrate supplied?

The Acid Concentrate 45x is supplied by Baxter Healthcare Corp in either liquid or powder form to accommodate the requirements of the hemodialysis machine setup.

What is the regulatory status of this device?

The Acid Concentrate 45x has received FDA 510k clearance. It is classified as an FDA class 2 device under regulation number 876.5820.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Acid Concentrate 45x (2.0k, 3.1ca), Model 5m8001a, Acid Concentrate 45x ..., Acid Concentrate 45x (2.0k, 3.1ca), Model 5m8001a, Acid Concentrate 45x ..., Acid Concentrate 45x (2.0k, 3.1ca), Model 5m8001a, Acid Concentrate 45x ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Baxter Healthcare Corp

Sources (1)

  • FDA 510(k) K090002 24 fields · synced Oct 6, 2026