# K090002: Acid Concentrate 45X (2.0K, 3.1CA), Model 5M8001A, Acid Concentrate 45X (2.0K, 2.5CA), Model 5M8002A

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Aug 7, 2009 after 217 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K781967 (1978). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792213: Renal Systems Hemodialysis Concentrate, Renal Systems, Inc. (1980) Summary page 2.
- K781967: Hemodialysis Concentrate, Sodiu, Renal Systems, Inc. (1978) Summary page 2.
- K954527: Rockwell Medical Supply LLC Hemodialysis Concentrate Solutions & Powders, Rockwell Medical Supply (1996) Summary page 2.

## Indications for use
Acid Concentrate is indicated for use as acid concentrate in hemodialysis therapy.

Source page: https://510kreport.com/device/K090002
Methodology: https://510kreport.com/methodology