# K946279: Prisma CFM (Continuous Fluid Management System)

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Renal Care, Inc.
- Decided: Feb 10, 1997 after 776 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
51 later devices descend from it; 8 cite it directly.
0 of 52 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
- K973322: Diapact CRRT (1998), 39 descendants of its own
- K030470: Nxstage System One (2003), 29 descendants of its own
- K041424: Nxstage System One (2004), 28 descendants of its own
- K050525: Nxstage System One (2005), 27 descendants of its own
- K062079: Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 (2006), 26 descendants of its own

Source page: https://510kreport.com/device/K946279
Methodology: https://510kreport.com/methodology