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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 / K251367

510(k) cleared

OptoMonitor 3

Opsens, Inc. · Jan 16, 2026 · K251367

FDA cleared the OptoMonitor 3 from Opsens, Inc. on Jan 16, 2026 under K251367, a traditional 510(k). The device falls under product code DXO, Transducer, Pressure, Catheter Tip, regulated at 21 CFR 870.2870 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 1, 2025. The decision came 260 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 Opsens, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251367?

K251367 is the FDA 510(k) for OptoMonitor 3, submitted by Opsens, Inc.. FDA's decision date was Jan 16, 2026, under product code DXO (Transducer, Pressure, Catheter Tip).

Who makes the OptoMonitor 3?

Opsens, Inc., based in Quebec, is the applicant of record for K251367.

How long did the K251367 review take?

FDA received the submission on May 1, 2025 and issued its decision on Jan 16, 2026, 260 days later.

← All decisions in January 2026