# K253942: Pulmonex II Xenon System (132-503)

- Pathway: 510(k) (Traditional)
- Applicant: Mirion Technologies (Capintec), Inc.
- Decided: Jul 7, 2026 after 210 days
- Product code: IYT (System, Rebreathing, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.1390
- 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 K810819 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810819: Medi/Nuclear #XE-102 Xenon/Master, Medi Nuclear Corp., Inc. (1981) Summary page 5.

## Indications for use
The Pulmonex II Xenon System is intended for the safe delivery and trapping of Xe-133 gas. The device is indicated for patients requiring lung ventilation studies. It is shielded for patient and operator safety.

Source page: https://510kreport.com/device/K253942
Methodology: https://510kreport.com/methodology