# K222897: Enlight 2100

- Pathway: 510(k) (Traditional)
- Applicant: Timpel S.A.
- Decided: Mar 7, 2023 after 165 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: 9 generations back to K902859 (1991). 43 ancestors in all.
2 later devices descend from it; 2 cite it directly.
4 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211135: Enlight 2100, Timpel S.A. (2022) Summary page 4.
- K103578: Philips NM3 Respiratory Monitor with Ventassist, Respironics Novametrix, LLC (2011) Summary page 4.

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

## Indications for use
ENLIGHT 2100 is a non-invasive, radiation free medical device that provides information from impedance variation from 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 thorax. ENLIGHT 2100 also provides respiratory parameters based on spirometric monitoring. It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 – 134 cm. ENLIGHT 2100 does not measure regional ventilation of the lungs

Source page: https://510kreport.com/device/K222897
Methodology: https://510kreport.com/methodology