# K781967: Hemodialysis Concentrate, Sodiu

- Pathway: 510(k) (Traditional)
- Applicant: Renal Systems, Inc.
- Decided: Dec 7, 1978 after 13 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K090002: Acid Concentrate 45X (2.0K, 3.1CA), Model 5M8001A, Acid Concentrate 45X (2.0K, 2.5CA), Model 5M8002A (2009), 0 descendants of its own
- K020230: Diasol-Bicarb (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K781967
Methodology: https://510kreport.com/methodology