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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 / July 2026 / K260880

510(k) cleared

SedLine Sedation Monitor

Masimo Corporation · Jul 10, 2026 · K260880

FDA cleared the SedLine Sedation Monitor from Masimo Corporation on Jul 10, 2026 under K260880, a traditional 510(k). The device falls under product code OLW, Index-Generating Electroencephalograph Software, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Mar 17, 2026. The decision came 115 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), K254209 (Radius VSM and Accessories).

Questions & Answers

What did FDA clear under K260880?

K260880 is the FDA 510(k) for SedLine Sedation Monitor, submitted by Masimo Corporation. FDA's decision date was Jul 10, 2026, under product code OLW (Index-Generating Electroencephalograph Software).

Who makes the SedLine Sedation Monitor?

Masimo Corporation, based in Irvine, CA, is the applicant of record for K260880.

How long did the K260880 review take?

FDA received the submission on Mar 17, 2026 and issued its decision on Jul 10, 2026, 115 days later.

← All decisions in July 2026

Sources