# K843963: Dialysate Concentrate for Hemodialysis-Liquid/Powd

- Pathway: 510(k) (Traditional)
- Applicant: Renal Systems, Inc.
- Decided: Jan 7, 1985 after 88 days
- Product code: FKQ (System, Dialysate Delivery, Central Multiple Patient)
- 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K131202: Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder (45X), Medicalyte (R) Bicarbonate Powder (35X (2014), 4 descendants of its own
- 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
- Apr 20, 2021 · Class II · Z-1859-2021: The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.

Source page: https://510kreport.com/device/K843963
Methodology: https://510kreport.com/methodology