# K071387: Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-LB

- Pathway: 510(k) (Special)
- Applicant: Fresenius Medical Care North America
- Decided: Jun 15, 2007 after 28 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 6 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981043 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981043: Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder, Renalsol-Acetate Concentrate Liquid & Powder, Biosol, Solution Technologies (1998) Summary page 2.

## Recalls of this device
- Jul 16, 2015 · Class II · Z-2373-2015: Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
- May 20, 2015 · Class II · Z-1827-2015: Bacterial contamination.
- Jun 23, 2014 · Class II · Z-2686-2014: Product was held at temperature above the labeled recommended storage temperature
- May 1, 2014 · Class III · Z-1739-2014: Container cap may contain foreign material- 0.60% - 0.80% Manganese
- Apr 10, 2014 · Class I · Z-1639-2014: Naturalyte Liquid Bicarbonate maybe contaminated
- Mar 23, 2011 · Not classified · Z-2551-2011: Mislabeled: incorrect lot number printed on case labels

## Indications for use
This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates

Source page: https://510kreport.com/device/K071387
Methodology: https://510kreport.com/methodology