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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 / February 2026 / K251200

510(k) cleared

Vital Signs

Oxehealth Limited · Feb 2, 2026 · K251200

FDA cleared the Vital Signs from Oxehealth Limited on Feb 2, 2026 under K251200, a traditional 510(k). The device falls under product code QME, Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate, regulated at 21 CFR 870.2785 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 18, 2025. The decision came 290 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 Oxehealth Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251200?

K251200 is the FDA 510(k) for Vital Signs, submitted by Oxehealth Limited. FDA's decision date was Feb 2, 2026, under product code QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate).

Who makes the Vital Signs?

Oxehealth Limited, based in Abingdon, is the applicant of record for K251200.

How long did the K251200 review take?

FDA received the submission on Apr 18, 2025 and issued its decision on Feb 2, 2026, 290 days later.

← All decisions in February 2026