# K864265: Hemodialysis Bath Concentrate Solutions for Hemodi

- Pathway: 510(k) (Traditional)
- Applicant: Dial Medical of Florida, Inc.
- Decided: Mar 17, 1987 after 139 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.
41 later devices descend from it; 4 cite it directly.
0 of 42 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
- K013448: Prismasate (2002), 18 descendants of its own
- K022913: Nxstage Premixed Dialysate (2002), 12 descendants of its own
- K010131: PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub (2002), 12 descendants of its own
- K033386: Nxstage Pureflow Solution (2003), 10 descendants of its own
- K042045: Nxstage Pureflow-B Solution (2004), 8 descendants of its own

Source page: https://510kreport.com/device/K864265
Methodology: https://510kreport.com/methodology