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 / June 2026 / K254209

510(k) cleared

Radius VSM and Accessories

Masimo Corporation · Jun 4, 2026 · K254209

FDA cleared the Radius VSM and Accessories from Masimo Corporation on Jun 4, 2026 under K254209, a traditional 510(k). The device falls under product code MHX, Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), regulated at 21 CFR 870.1025 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 29, 2025. The decision came 157 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Masimo Corporation has 2 other decisions in the tracker over the last 12 months: K253417 (Masimo Root Monitoring System), K260880 (SedLine Sedation Monitor).

Questions & Answers

What did FDA clear under K254209?

K254209 is the FDA 510(k) for Radius VSM and Accessories, submitted by Masimo Corporation. FDA's decision date was Jun 4, 2026, under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)).

Who makes the Radius VSM and Accessories?

Masimo Corporation, based in Irvine, CA, is the applicant of record for K254209.

How long did the K254209 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Jun 4, 2026, 157 days later.

← All decisions in June 2026

Sources