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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 / January 2026 / K251900

510(k) cleared

MY01 Continuous Compartmental Pressure Monitor

MY01, Inc. · Jan 16, 2026 · K251900

FDA cleared the MY01 Continuous Compartmental Pressure Monitor from MY01, Inc. on Jan 16, 2026 under K251900, a traditional 510(k). The device falls under product code LXC, Monitor, Pressure, Intracompartmental as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jun 20, 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 MY01, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251900?

K251900 is the FDA 510(k) for MY01 Continuous Compartmental Pressure Monitor, submitted by MY01, Inc.. FDA's decision date was Jan 16, 2026, under product code LXC (Monitor, Pressure, Intracompartmental).

Who makes the MY01 Continuous Compartmental Pressure Monitor?

MY01, Inc., based in Montreal, is the applicant of record for K251900.

How long did the K251900 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Jan 16, 2026, 210 days later.

← All decisions in January 2026