# K231086: CPM System

- Pathway: 510(k) (Traditional)
- Applicant: Analog Devices, Inc.
- Decided: Dec 22, 2023 after 249 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 Sensinel™ CPM 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 (Obtained from left chest area) • 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 Sensinel™ CPM Wearable and Base Station for storage and analysis. The CPM Wearable is intended for use on general care adult patients 18 years of age or older to provide physiological information. The data from the CPM System is intended for use by healthcare professionals as an aid to diagnosis and treatment. The 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 CPM Wearable does not produce alarms and is not intended for active patient monitoring (in real-time). The Sensinel™ CPM System is contraindicated for those patients with life threatening arrhythmias requiring immediate medical intervention.

Source page: https://510kreport.com/device/K231086
Methodology: https://510kreport.com/methodology