# K131202: Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder (45X), Medicalyte (R) Bicarbonate Powder (35X

- Pathway: 510(k) (Traditional)
- Applicant: Dialysis Medical Solutions, LLC
- Decided: Apr 3, 2014 after 339 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K843963 (1985). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954527: Rockwell Medical Supply LLC Hemodialysis Concentrate Solutions & Powders, Rockwell Medical Supply (1996) Summary page 2.
- K843963: Dialysate Concentrate for Hemodialysis-Liquid/Powd, Renal Systems, Inc. (1985) Summary page 2.
- K012328: Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate Powder, Di-Chem, Inc. (2002) Summary page 6.

## Most influential descendants
- 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

## Recalls of this device
- Aug 5, 2026 · Class II · Z-3134-2026: Hemodialysis concentrates contain high endotoxin levels

## Indications for use
For DB-203; DB-204; DB-205: This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 36.83x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis. For DB-206; DB-207; DB-208: This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 45x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis. For DB-209; DB-210; DB-211: This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 35x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.

Source page: https://510kreport.com/device/K131202
Methodology: https://510kreport.com/methodology