# K211135: Enlight 2100

- Pathway: 510(k) (Traditional)
- Applicant: Timpel S.A.
- Decided: Jan 6, 2022 after 265 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: 1 generation back to DEN170072 (2018). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170072: Enlight 1810, Timpel, Inc. (2018) Summary page 4.

## Most influential descendants
- K222897: Enlight 2100 (2023), 2 descendants of its own
- K250464: Enlight 2100 (TPL-E2103-0) (2025), 0 descendants of its own
- K243765: LuMon (TM) System (2025), 0 descendants of its own
- K222466: AirTom (2023), 0 descendants of its own

## Indications for use
ENLIGHT 2100 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient’s thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user’s assessment of variations in regional air content within a cross section of a patient’s lungs. It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 - 134cm. ENLIGHT 2100 does not measure regional ventilation of the lungs.

Source page: https://510kreport.com/device/K211135
Methodology: https://510kreport.com/methodology