# K052253: Modification to: Dryac Acid Concentrate Mix for Bicarbonate Hemodialysis

- Pathway: 510(k) (Special)
- Applicant: Gambro Renal Products
- Decided: Nov 2, 2005 after 76 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 K011368 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011368: Dry AC Acid Concentrate Mix for Bicarbonate Hemodialysis, Gambro Renal Products (2001) Summary page 1.

## Indications for use
Gambro DryAC acid concentrate mix for bicarbonate hemodialysis is indicated for use with concentrated bicarbonate solution in 3-stream proportioning artificial kidney equipment using purified, AAMI standard water.

Source page: https://510kreport.com/device/K052253
Methodology: https://510kreport.com/methodology