# K000028: Renaflo II HF 2000 Hemofilter

- Pathway: 510(k) (Traditional)
- Applicant: Minntech Corp.
- Decided: Apr 4, 2000 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Renaflo® II HF 1200 Hemofilter: named in the summary without a submission number

## Indications for use
The Renaflo® IT HF 2000 Hemofilter is intended for use in patients with fluid overload. uremia and/or electrolyte disturbances associated with oligoanuria acute renal failure. 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/K000028
Methodology: https://510kreport.com/methodology