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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 / August 2026 / K253417

510(k) cleared

Masimo Root Monitoring System

Masimo Corporation · Aug 12, 2026 · K253417

FDA cleared the Masimo Root Monitoring System from Masimo Corporation on Aug 12, 2026 under K253417, a traditional 510(k). The device falls under product code MWI, Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), regulated at 21 CFR 870.2300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Oct 1, 2025. The decision came 315 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: K260880 (SedLine Sedation Monitor), K254209 (Radius VSM and Accessories).

Questions & Answers

What did FDA clear under K253417?

K253417 is the FDA 510(k) for Masimo Root Monitoring System, submitted by Masimo Corporation. FDA's decision date was Aug 12, 2026, under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)).

Who makes the Masimo Root Monitoring System?

Masimo Corporation, based in Irvine, CA, is the applicant of record for K253417.

How long did the K253417 review take?

FDA received the submission on Oct 1, 2025 and issued its decision on Aug 12, 2026, 315 days later.

← All decisions in August 2026

Sources