# K243216: Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)

- Pathway: 510(k) (Traditional)
- Applicant: Analog Devices
- Decided: Dec 10, 2024 after 68 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ADI Sensinel CPM (Cardiopulmonary Management) System is a wireless remote monitoring system intended for use by healthcare professionals for spot checking of physiological data in home and healthcare settings. This can include: * ECG * Heart Auscultation Sounds * Skin Temperature * Thoracic Impedance (including Changes in Thoracic Impedance) * Respiration Rate and relative changes in Tidal Volume * Heart Rate * Diastolic Heart Sounds Strength * Body Posture (including Tilt Angle) Data are transmitted wirelessly from the ADI CPM (Cardiopulmonary Management) Wearable and Base Station for storage and analysis. The device is intended for use on general care adult patients who are 18 years of age or older to provide physiological information. The data from the ADI CPM (Cardiopulmonary Management) System Platform are intended for use by healthcare professional as an aid to diagnosis and treatment. The ADI CPM System is intended to be used by patients at rest and not performing any activities or movements. This system is for spot checking and does not have continuous monitoring capability. The device does not produce alarms and is not intended for active patient monitoring (real-time). The ADI CPM System in contraindicated for those patients with life threatening arrhythmias requiring immediate medical intervention.

Source page: https://510kreport.com/device/K243216
Methodology: https://510kreport.com/methodology