# K991520: Fresenius on Line Clearance Monitor with the Addition of Access Flow Determination

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Jul 30, 1999 after 88 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 and for access flow estimation for those patients undergoing acute or chronic hemodialysis.

Source page: https://510kreport.com/device/K991520
Methodology: https://510kreport.com/methodology