# K854011: Renalfo Hemofilter Cavhd

- Pathway: 510(k) (Traditional)
- Applicant: Renal Systems, Inc.
- Decided: Nov 5, 1985 after 36 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.
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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K994198: Hemofeel-CH, Models CH-0.35L, CH-0.6L, CH-1.0L (2000), 0 descendants of its own

Source page: https://510kreport.com/device/K854011
Methodology: https://510kreport.com/methodology