# K222466: AirTom

- Pathway: 510(k) (Traditional)
- Applicant: Bilab
- Decided: Jun 30, 2023 after 318 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: 2 generations back to DEN170072 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
AirTom is a non-invasive, non-radiation medical device that provides information of local impedance variations 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 patients in a professional healthcare facility, whose chest circumference is within the range of 32 ~ 130 cm. AirTom does not measure regional ventilation of the lungs.

Source page: https://510kreport.com/device/K222466
Methodology: https://510kreport.com/methodology