# K955423: Pack H Hemodialysis Urea Kinetic Modeling Software Program

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius USA, Inc.
- Decided: Jun 13, 1996 after 198 days
- Product code: FKP (System, Dialysate Delivery, Single Patient)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K130460: Nxstage Dosing Calculator (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K955423
Methodology: https://510kreport.com/methodology