# K250634: BCM2-Body Composition Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Nov 24, 2025 after 266 days
- Product code: DSB (Plethysmograph, Impedance)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K922218 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142503: Imed-Z Fluid Status Monitor, Intersection Medical, Inc. (2015) Summary page 5.
- K904109: Bio-Impedance Analyzer, Xitron Technologies, Inc. (1991) Summary page 5.

## Indications for use
The BCM2 is intended for use, under the direction of a physician, for the noninvasive intermittent measurement of fluid status in patients with end-stage kidney disease (ESKD) including those receiving maintenance dialysis. The device does not generate any real-time alarms and outputs from the device should be used in the context of all clinical data to assess a patient's fluid status. The device is intended for use in patients 18 years and older.

Source page: https://510kreport.com/device/K250634
Methodology: https://510kreport.com/methodology