# K030497: Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX Series

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care
- Decided: May 20, 2003 after 90 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 14 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911459 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911459: Granulyte Powder Dialysate Concentrate and Mixing, Fresenius USA, Inc. (1991) Summary page 1.
- K922005: Granulyte Dialysate Concentrate, Fresenius USA, Inc. (1994) Summary page 1.

## Most influential descendants
- K192209: Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate (2020), 0 descendants of its own

## Recalls of this device
- Oct 9, 2018 · Class III · Z-0516-2019: Discolored powder has confirmed the presence of a foreign substance
- Oct 9, 2018 · Class III · Z-0518-2019: Discolored powder has confirmed the presence of a foreign substance
- Oct 9, 2018 · Class III · Z-0517-2019: Discolored powder has confirmed the presence of a foreign substance
- Nov 26, 2012 · Class III · Z-0677-2013: GranuFlo Dry Acid Concentrate may show discoloration
- Nov 26, 2012 · Class III · Z-0678-2013: GranuFlo Dry Acid Concentrate may show discoloration
- Nov 26, 2012 · Class III · Z-0681-2013: GranuFlo Dry Acid Concentrate may show discoloration
- Nov 26, 2012 · Class III · Z-0682-2013: GranuFlo Dry Acid Concentrate may show discoloration
- Nov 26, 2012 · Class III · Z-0676-2013: GranuFlo Dry Acid Concentrate may show discoloration
- Nov 26, 2012 · Class III · Z-0679-2013: GranuFlo Dry Acid Concentrate may show discoloration
- Nov 26, 2012 · Class III · Z-0680-2013: GranuFlo Dry Acid Concentrate may show discoloration
- Nov 26, 2012 · Class III · Z-0683-2013: GranuFlo Dry Acid Concentrate may show discoloration
- Nov 26, 2012 · Class III · Z-0684-2013: GranuFlo Dry Acid Concentrate may show discoloration
- Mar 29, 2012 · Class I · Z-1827-2012: Risk of Alkalosis with acetate containing dialysis acid concentrates
- Mar 29, 2012 · Class I · Z-1826-2012: Risk of Alkalosis with acetate containing dialysis acid concentrates

## Indications for use
The Fresenius NaturalyteO GranufloO Dry Acid Concentrate is indicated in the treatment of acute and chronic renal failure durjng the hemodialysis procedure. This concentrate is formulated to be used with a three-stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

Source page: https://510kreport.com/device/K030497
Methodology: https://510kreport.com/methodology