FDA 510(k) clearance · back to tracker

Sensinel Cardiopulmonary Management (CPM) System

Analog Devices cleared K260801 on 2026-10-16, decision: substantially equivalent

K-number

K260801

Sponsor

Analog Devices

Device

Sensinel Cardiopulmonary Management (CPM) System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-16

Product code

MWI

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.2300

Official FDA record

Open K260801on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.