# K050827: Normocard 25 (Sterile Bicarbonate Renal Dialysis Concentrate)

- Pathway: 510(k) (Traditional)
- Applicant: Dialysis Solutions, Inc.
- Decided: Aug 22, 2005 after 143 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Normocarb MT 35: named in the summary without a submission number

## Indications for use
NORMOCARB™ 25 Sterile Bicarbonate Renal Dialysis Concentrate, after dilution, is indicated for use as a dialysate, in Continuous Renal Replacement Therapy (CRRT).

Source page: https://510kreport.com/device/K050827
Methodology: https://510kreport.com/methodology