# K992275: Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol Hemoconcentrator W/Tubing Set F3000TS

- Pathway: 510(k) (Special)
- Applicant: Fresenius USA, Inc.
- Decided: Aug 4, 1999 after 28 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: 2 generations back to K902837 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974584: Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS, Fresenius USA, Inc. (1998) Summary page 2.

## Indications for use
The Fresenius F Series Hemoconcentrators are indicated to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

Source page: https://510kreport.com/device/K992275
Methodology: https://510kreport.com/methodology