Cleared Traditional

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)

K243216 · Analog Devices · Cardiovascular

Dec 2024

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K243216 is an FDA 510(k) clearance for the Sensinel Cardiopulmonary Management (CPM) System (ADCP1100), a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Analog Devices (Wilmington, US). The FDA issued a Cleared decision on December 10, 2024, 68 days after receiving the submission on October 3, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K243216 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 03, 2024
Decision Date	December 10, 2024
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300