Cleared Traditional

Re:Balans

K243727 · Mode Sensors AS · Cardiovascular
Oct 2025
Decision
317d
Days
Class 2
Risk

About This 510(k) Submission

K243727 is an FDA 510(k) clearance for the Re:Balans, a Plethysmograph, Impedance (Class II — Special Controls, product code DSB), submitted by Mode Sensors AS (Trondheim, NO). The FDA issued a Cleared decision on October 16, 2025, 317 days after receiving the submission on December 3, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number K243727 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2024
Decision Date October 16, 2025
Days to Decision 317 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSB — Plethysmograph, Impedance
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2770