Cleared Traditional

K243765 - LuMon(TM) System
(FDA 510(k) Clearance)

K243765 · Sentec AG · Anesthesiology
Aug 2025
Decision
244d
Days
Class 2
Risk

K243765 is an FDA 510(k) clearance for the LuMon(TM) System, a Ventilatory Electrical Impedance Tomograph (Class II — Special Controls, product code QEB), submitted by Sentec AG (Therwil, CH). The FDA issued a Cleared decision on August 7, 2025, 244 days after receiving the submission on December 6, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1505.

Submission Details

510(k) Number K243765 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2024
Decision Date August 07, 2025
Days to Decision 244 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code QEB — Ventilatory Electrical Impedance Tomograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1505
Definition A Ventilatory Electrical Impedance Tomograph Is A Prescription Non-invasive, Non-radiological Ventilatory Device That Provides An Assessment Of Local Impedance Variation Within A Cross-section Of A Patient?s Thorax.