# K012547: Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate Solution

- Pathway: 510(k) (Traditional)
- Applicant: Di-Chem, Inc.
- Decided: Jan 18, 2002 after 164 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 2 (1 Class I)
- 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.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Aug 5, 2026 · Class II · Z-3133-2026: Hemodialysis concentrates contain high endotoxin levels
- Apr 11, 2025 · Class I · Z-1730-2025: Potential for the presence of visible foreign matter.

## Indications for use
The Di-Chem Liquid Sodium Bicarbonate solutions arc indicated for use in the treatment of acute and chronic hemodialysis and to be used with an appropriate hemodialysis machine/monitor.

Source page: https://510kreport.com/device/K012547
Methodology: https://510kreport.com/methodology