# K851431: Hemodialysis Concentrate Additives

- Pathway: 510(k) (Traditional)
- Applicant: Dana Laboratories
- Decided: Jun 12, 1985 after 63 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Nov 5, 2025 · Class II · Z-0989-2026: Safety and efficacy of dialysis acid concentrate cannot be assured
- Nov 5, 2025 · Class II · Z-0987-2026: Safety and efficacy of dialysis acid concentrate cannot be assured
- Nov 5, 2025 · Class II · Z-0988-2026: Safety and efficacy of dialysis acid concentrate cannot be assured
- Nov 5, 2025 · Class II · Z-0990-2026: Safety and efficacy of dialysis acid concentrate cannot be assured
- Nov 5, 2025 · Class II · Z-0991-2026: Safety and efficacy of dialysis acid concentrate cannot be assured
- Nov 5, 2025 · Class II · Z-0992-2026: Safety and efficacy of dialysis acid concentrate cannot be assured
- Jul 27, 2022 · Class II · Z-0207-2025: Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label.
- Apr 30, 2020 · Class II · Z-2402-2020: Incorrect labeling of dialysate concentration for hemodialysis.

Source page: https://510kreport.com/device/K851431
Methodology: https://510kreport.com/methodology