# K994198: Hemofeel-CH, Models CH-0.35L, CH-0.6L, CH-1.0L

- Pathway: 510(k) (Traditional)
- Applicant: Toray Industries (America), Inc.
- Decided: Aug 25, 2000 after 256 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
Longest line of descent: 1 generation back to K854011 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854011: Renalfo Hemofilter Cavhd, Renal Systems, Inc. (1985) Summary page 1.
- K935471: Filtryzer (TM), Toray Industries (America), Inc. (1995) Summary page 1.

## Indications for use
The Hemofeel™-CH hemofilter is indicated for use in the prevention or treatment of fluid overload, electrolyte and acid/base imbalances in cases of acute renal failure or toxemia with oliguria or anuria. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy.

Source page: https://510kreport.com/device/K994198
Methodology: https://510kreport.com/methodology