Pulmonex II Xenon System (132-503)— 510(k) K253942

Name: FDA 510(k) clearance K253942
Creator: U.S. Food and Drug Administration
Published: 2026-07-07

Substantially Equivalent

Mirion Technologies (Capintec), Inc.

FDA 510(k) clearance K253942 for Pulmonex II Xenon System (132-503), Substantially Equivalent on 2026-07-07. Applicant: Mirion Technologies (Capintec), Inc.. Device class: 2.

Summary

Mirion Technologies (Capintec)'s Pulmonex II Xenon System (132-503) is filed under IYT, radionuclide rebreathing systems. The record gives the model as 132-503 but no specs.

Class II, 21 CFR 892.1390. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).

Mirion filed from Florham Park, New Jersey. Review took 210 calendar days (December 9, 2025 to July 7, 2026). The record flags it as a third-party review.

Clearance details

Applicant: Mirion Technologies (Capintec), Inc.
Product code: Product code IYT
Device class: Class 2
Regulation: 21 CFR 892.1390
Advisory panel: Radiology
Date received: 2025-12-09
Decision date: 2026-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Florham Park, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYT

view all

K200916 — Patient Administration Set2020-09-01
K953513 — XENON CIRCUIT1995-11-03
K952223 — XENON GAS BREATHING CIRCUIT1995-08-11
K914747 — XENON CIRCUIT1992-02-27
K913416 — TETLEY PATIENT ADMINISTRATION SET1991-10-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.