# K243727: Re:Balans

- Pathway: 510(k) (Traditional)
- Applicant: Mode Sensors AS
- Decided: Oct 16, 2025 after 317 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.

## Indications for use
The Re:Balans is intended for use under the direction of a physician, for the non-invasive monitoring of patients with fluid management-related health conditions. The device measures thoracic bioimpedance in patients to assist the physician in fluid management assessment. The device is indicated for adult patients with fluid overload such as end-stage renal disease, and patients at risk of dehydration. The device does not generate any real-time alarms for consideration by the user at home or by a healthcare professional. Data from the device should be used in the context of all clinical data to make determinations of a patient's fluid status.

Source page: https://510kreport.com/device/K243727
Methodology: https://510kreport.com/methodology