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The Tracker / October 2026 / K260801

510(k) cleared

Sensinel Cardiopulmonary Management (CPM) System

Analog Devices · Oct 16, 2026 · K260801

FDA cleared the Sensinel Cardiopulmonary Management (CPM) System from Analog Devices on Oct 16, 2026 under K260801, 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 Mar 11, 2026. The decision came 219 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 Analog Devices in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260801?

K260801 is the FDA 510(k) for Sensinel Cardiopulmonary Management (CPM) System, submitted by Analog Devices. FDA's decision date was Oct 16, 2026, under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)).

Who makes the Sensinel Cardiopulmonary Management (CPM) System?

Analog Devices, based in Wilmington, MA, is the applicant of record for K260801.

How long did the K260801 review take?

FDA received the submission on Mar 11, 2026 and issued its decision on Oct 16, 2026, 219 days later.

← All decisions in October 2026