# DEN170072: Enlight 1810

- Pathway: De Novo (Direct)
- Applicant: Timpel, Inc.
- Decided: Dec 20, 2018 after 447 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
No predicates in its family tree.
5 later devices descend from it; 1 cites 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K211135: Enlight 2100 (2022), 4 descendants of its own
- 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 1810 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 patients in a hospital setting, whose thorax perimeter is within the range of 78-122 cm.

Source page: https://510kreport.com/device/DEN170072
Methodology: https://510kreport.com/methodology