# K012328: Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate Powder

- Pathway: 510(k) (Traditional)
- Applicant: Di-Chem, Inc.
- Decided: Jan 18, 2002 after 179 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have 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.

## Most influential descendants
- K131202: Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder (45X), Medicalyte (R) Bicarbonate Powder (35X (2014), 4 descendants of its own
- K171750: Citric Complete Dry Citric Acid (45X) (2018), 2 descendants of its own
- K223431: Citric Complete Liquid Citric Acid Concentrate (2023), 1 descendant of its own
- K260799: Nipro Dry Acid Concentrate Mixer (2026), 0 descendants of its own
- K193155: Nipro Dry Complete Dry Acid Concentrate for Hemodialysis (2020), 0 descendants of its own

## Indications for use
The DI-CHEM Sodium Bicarbonate powders are 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/K012328
Methodology: https://510kreport.com/methodology