# K944767: Dialysis Machine with Dialysate Ultrafilter

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius USA, Inc.
- Decided: Nov 29, 1995 after 428 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K182367: DIASAFEplusUS (2019), 3 descendants of its own
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own
- K243505: 5008X Hemodialysis System (2025), 1 descendant of its own
- K251851: DIASAFEplusUS (F00013010) (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K944767
Methodology: https://510kreport.com/methodology