# K070177: Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 Series - Pathway: 510(k) (Special) - Applicant: Fresenius Medical Care North America - Decided: Mar 29, 2007 after 70 days - Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)) - Device class: 2 - Regulation: 21 CFR 876.5820 - Recalls of this device: 35 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K810925 (1981). 3 ancestors in all. No later device cites it as a predicate yet. 0 of 4 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K810925: Naturalyte Bicarbonate Dialysate Concen., Erika, Inc. (1981) Summary page 2. - K823115: Naturalyte Bicarbonate Dialysate 4400, Erika, Inc. (1982) Summary page 2. - K852310: Naturalyte Bicarbonate Concentrate-Dry Pack, Erika, Inc. (1985) Summary page 2. ## Recalls of this device - Oct 4, 2022 · Class II · Z-0181-2023: The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains pot - Dec 17, 2020 · Class II · Z-0942-2021: Bottles Missing Product Label - Nov 23, 2020 · Class II · Z-0832-2021: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium c - Nov 23, 2020 · Class II · Z-0834-2021: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium c - Nov 23, 2020 · Class II · Z-0836-2021: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium c - Nov 23, 2020 · Class II · Z-0838-2021: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium c - Nov 23, 2020 · Class II · Z-0833-2021: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium c - Nov 23, 2020 · Class II · Z-0841-2021: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium c - Nov 23, 2020 · Class II · Z-0835-2021: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium c - Nov 23, 2020 · Class II · Z-0837-2021: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium c - Nov 23, 2020 · Class II · Z-0840-2021: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium c - Nov 23, 2020 · Class II · Z-0831-2021: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium c - Nov 23, 2020 · Class II · Z-0839-2021: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium c - Nov 7, 2020 · Class II · Z-0811-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0812-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0813-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0815-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0816-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0817-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0818-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0820-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0821-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0823-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0825-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0826-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0827-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0814-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0819-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0822-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0824-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0828-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - Nov 7, 2020 · Class II · Z-0829-2021: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. - May 2, 2018 · Class II · Z-2110-2018: The bottles are mislabeled with an incorrect part number. - Sep 29, 2017 · Class II · Z-1010-2018: The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L. - Jan 18, 2016 · Class II · Z-0887-2016: On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituent ## Indications for use Acid Concentrate for Bicarbonate Dialysis Source page: https://510kreport.com/device/K070177 Methodology: https://510kreport.com/methodology