Cleared Traditional

K260801 - Sensinel Cardiopulmonary Management (CPM) System

K260801 is an FDA 510(k) clearance for Sensinel Cardiopulmonary Management (CP..., manufactured by Analog Devices. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K260801 · Analog Devices · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
219d
Days
Class 2
Risk

K260801 is an FDA 510(k) clearance for the Sensinel Cardiopulmonary Management (CPM) System. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Analog Devices (Wilmington, US). The FDA issued a Cleared decision on October 16, 2026 after a review of 219 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K260801

510(k) Number K260801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2026
Decision Date October 16, 2026
Days to Decision 219 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 125d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 308
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K260801.
Vital Signs Monitor (CLEO2)
K260438 · Infinium Medical, Inc. · Aug 2026
Masimo Root Monitoring System
K253417 · Masimo Corporation · Aug 2026
Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)
K253196 · Midmark Corporation · Jun 2026
c-med0 alpha
K253436 · Cosinuss GmbH · Apr 2026
WAVE Clinical Platform (2.0.000)
K250135 · Baxter Healthcare Corp/ Excel Medical · Jan 2026
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
K241766 · Fysicon BV · Aug 2025
K260801 · Sensinel Cardiopulmonary Management (CPM) System
Download PDF FDA Summary Analog Devices