# K250464: Enlight 2100 (TPL-E2103-0)

- Pathway: 510(k) (Traditional)
- Applicant: Timpel S.A.
- Decided: Sep 10, 2025 after 204 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) Summary page 5.

## 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 patients, from adults to infants, older than 29 days, 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/K250464
Methodology: https://510kreport.com/methodology