# K243765: LuMon (TM) System

- Pathway: 510(k) (Traditional)
- Applicant: Sentec AG
- Decided: Aug 7, 2025 after 244 days
- Product code: QEB (Ventilatory Electrical Impedance Tomograph)
- Device class: 2
- Regulation: 21 CFR 868.1505
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K902859 (1991). 44 ancestors in all.
No later device cites it as a predicate yet.
4 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222897: Enlight 2100, Timpel S.A. (2023). Our reading of the summary gave K222987, FDA’s number for Akunah REFLECT (Akunah Pty, Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Timpel Enlight 2100”.

## Indications for use
The LuMon™ System is a noninvasive, non-radiation device that provides information on regional impedance variation within a cross-section of a patient's thorax. Graphical and numerical information is presented to the user as an adjunctive tool to other clinical information to support the user to assess a patient’s respiratory condition. The LuMon™ System is indicated for neonatal and infant patients with chest circumferences between 16.5 - 50 cm and adolescent through adult patients with chest circumferences between 76 - 128 cm who are breathing spontaneously or require mechanical ventilation in professional healthcare facilities. Impedance-based respiratory rate monitoring is indicated for adults 22 years and older whose chest circumference is above 76 cm only. The LuMon™ System also displays selected physiological and respiratory parameters from supported bedside devices. The LuMon™ System does not measure regional ventilation of the lungs.

Source page: https://510kreport.com/device/K243765
Methodology: https://510kreport.com/methodology