# K961465: 2008H on Line Clearance Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius USA, Inc.
- Decided: Jul 3, 1997 after 442 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 K830190 (1983). 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)
- K830190: Ahr-3000 RE-Use Adaptor, Colorado Medical, Inc. (1983) Summary page 1.
- K841153: Adaptor HR-3000 Reuse, Colorado Medical, Inc. (1984) Summary page 1.
- (no number) Manual invasive blood urea determinations of dialyzer performance: named in the summary without a submission number

## Indications for use
The Fresenius On Line Clearance Monitor is intended to be used as a module with the Fresenius 2008H hemodialysis machine for determination of dialysis treatment urea clearance efficiency using Sodium conductivity as the surrogate solute marker.

Source page: https://510kreport.com/device/K961465
Methodology: https://510kreport.com/methodology