WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / December 2025 / K252068

510(k) cleared

MC2 Portable X-ray System

Oxos Medical · Dec 22, 2025 · K252068

FDA cleared the MC2 Portable X-ray System from Oxos Medical on Dec 22, 2025 under K252068, a traditional 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 1, 2025. The decision came 174 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 Oxos Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252068?

K252068 is the FDA 510(k) for MC2 Portable X-ray System, submitted by Oxos Medical. FDA's decision date was Dec 22, 2025, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the MC2 Portable X-ray System?

Oxos Medical, based in Atlanta, GA, is the applicant of record for K252068.

How long did the K252068 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Dec 22, 2025, 174 days later.

← All decisions in December 2025