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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 / April 2026 / K252407

510(k) cleared

OxyGo Portable Oxygen Concentrator (1400-7000)

Mv Life, LLC · Apr 23, 2026 · K252407

FDA cleared the OxyGo Portable Oxygen Concentrator (1400-7000) from Mv Life, LLC on Apr 23, 2026 under K252407, a traditional 510(k). The device falls under product code CAW, Generator, Oxygen, Portable, regulated at 21 CFR 868.5440 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jul 31, 2025. The decision came 266 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 Mv Life, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252407?

K252407 is the FDA 510(k) for OxyGo Portable Oxygen Concentrator (1400-7000), submitted by Mv Life, LLC. FDA's decision date was Apr 23, 2026, under product code CAW (Generator, Oxygen, Portable).

Who makes the OxyGo Portable Oxygen Concentrator (1400-7000)?

Mv Life, LLC, based in Orlando, FL, is the applicant of record for K252407.

How long did the K252407 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Apr 23, 2026, 266 days later.

← All decisions in April 2026