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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 / K260907

510(k) cleared

BIS Advance pEEG Module

Covidien LP · Aug 13, 2026 · K260907

FDA cleared the BIS Advance pEEG Module from Covidien LP on Aug 13, 2026 under K260907, 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 19, 2026. The decision came 147 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Covidien LP has 8 other decisions in the tracker over the last 12 months: K253527 (Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)), K253984 (Instrument Exit Point on Touch Surgery Aide), K253030 (Capnostream35 Portable Respiratory Monitor (PM35MN)), K251025 (Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)).

Questions & Answers

What did FDA clear under K260907?

K260907 is the FDA 510(k) for BIS Advance pEEG Module, submitted by Covidien LP. FDA's decision date was Aug 13, 2026, under product code OLW (Index-Generating Electroencephalograph Software).

Who makes the BIS Advance pEEG Module?

Covidien LP, based in Mansfield, MA, is the applicant of record for K260907.

How long did the K260907 review take?

FDA received the submission on Mar 19, 2026 and issued its decision on Aug 13, 2026, 147 days later.

← All decisions in August 2026