Sensinel Cardiopulmonary Management (CPM) System— 510(k) K260801

Name: FDA 510(k) clearance K260801
Creator: U.S. Food and Drug Administration
Published: 2026-10-16

Substantially Equivalent

Analog Devices

FDA 510(k) clearance K260801 for Sensinel Cardiopulmonary Management (CPM) System, Substantially Equivalent on 2026-10-16. Applicant: Analog Devices. Device class: 2.

Clearance details

Applicant: Analog Devices
Product code: Product code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2026-03-11
Decision date: 2026-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, MA, US

Download summary PDF View on FDA.gov ↗

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K253417 — Masimo Root Monitoring System2026-08-12
K253196 — Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)2026-06-12
K253436 — c-med0 alpha2026-04-30
K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

More clearances from Analog Devices

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K243216 — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)2024-12-10

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.