# K021060: Fresenius Icare Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Nov 13, 2002 after 225 days
- Product code: FKP (System, Dialysate Delivery, Single Patient)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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) Fresenius FDS08: named in the summary without a submission number

## Most influential descendants
- K040074: Oneview Interface (2004), 2 descendants of its own
- K133547: Nxstage System One with Nxview (2014), 1 descendant of its own
- K252377: NxStage System One with NxView (2026), 0 descendants of its own

## Indications for use
The Fresenius Care Monitoring System is a computer-based hemodialysis treatment monitoring system for adjunctive use with the Fresenius 2008 series dialysate delivery system when the patient is attended by trained personnel. This monitoring system is contraindicated as the sole method of monitoring a patient during hemodialysis.

Source page: https://510kreport.com/device/K021060
Methodology: https://510kreport.com/methodology