# K982926: Fresenius Blood Volume Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Sep 3, 1999 after 379 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 K972470 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972470: Crit-Line Monitor (Clmiii), In-Line Diagnostics Corp. (1997) Summary page 1.

## Indications for use
For non-invasive monitoring, in real time, of the estimated relative blood volume percent for patients undergoing hemodialysis so that technicians may make system adjustments in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting. The device can also provide estimated values of: (1) relative blood volume trend; (2) hematocrit; (3) hemoglobin and (4) blood water content or mass fraction of blood water in the total blood mass. The device is ONLY to be used in conjunction with the Fresenius Dialysis System 2008H.

Source page: https://510kreport.com/device/K982926
Methodology: https://510kreport.com/methodology