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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K253942

510(k) cleared

Pulmonex II Xenon System (132-503)

Mirion Technologies (Capintec), Inc. · Jul 7, 2026 · K253942

FDA cleared the Pulmonex II Xenon System (132-503) from Mirion Technologies (Capintec), Inc. on Jul 7, 2026 under K253942, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code IYT, System, Rebreathing, Radionuclide, regulated at 21 CFR 892.1390 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 9, 2025. The decision came 210 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Mirion Technologies (Capintec), Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253942?

K253942 is the FDA 510(k) for Pulmonex II Xenon System (132-503), submitted by Mirion Technologies (Capintec), Inc.. FDA's decision date was Jul 7, 2026, under product code IYT (System, Rebreathing, Radionuclide).

Who makes the Pulmonex II Xenon System (132-503)?

Mirion Technologies (Capintec), Inc., based in Florham Park, NJ, is the applicant of record for K253942.

How long did the K253942 review take?

FDA received the submission on Dec 9, 2025 and issued its decision on Jul 7, 2026, 210 days later.

← All decisions in July 2026