Cleared Traditional

K253942 - Pulmonex II Xenon System (132-503)

K253942 is the FDA 510(k) clearance for Pulmonex II Xenon System (132-503) by Mirion Technologies (Capintec), Inc.. It is a Class 2 Radiology device (product code IYT) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K253942 · Mirion Technologies (Capintec), Inc. · Radiology device
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Jul 2026
Decision
210d
Days
Class 2
Risk

K253942 is an FDA 510(k) clearance for the Pulmonex II Xenon System (132-503). Classified as System, Rebreathing, Radionuclide (product code IYT), Class II - Special Controls.

Submitted by Mirion Technologies (Capintec), Inc. (Florham Park, US). The FDA issued a Cleared decision on July 7, 2026 after a review of 210 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1390 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mirion Technologies (Capintec), Inc. devices

Submission Details

510(k) Number K253942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2025
Decision Date July 07, 2026
Days to Decision 210 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 107d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYT System, Rebreathing, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYT System, Rebreathing, Radionuclide

All 28
Devices cleared under the same product code (IYT) and FDA review panel - the closest regulatory comparables to K253942.
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