# K172801: ECG SENTINEL System

- Pathway: 510(k) (Traditional)
- Applicant: Cardiomedix, Inc.
- Decided: Oct 18, 2017 after 30 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K963725 (1997). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141813: Rhythmstar System, RhythMedix, LLC (2014) Summary page 4.

## Indications for use
The SENTINEL System is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records the ECG data and transfers the data to the Server. Upon detection by an ECG analysis algorithm at the Server the recorded cardiac activity is flagged for review by a medical professional. The data received from the SENTINEL device can be used by another cleared device for arrhythmia analysis, reporting and signal measurements. The SENTINEL System is not intended to sound any alarms. The device does not deliver any therapy, administer any drugs, provide interpretative or diagnostic statements or provide for any life support. The SENTINEL System is for prescription use only. User Population: The SENTINEL is intended for use by adult or children when supervised by an adult. The Sentinel is intended for use on adults and infants weighing more than 10 kg (22 lbs.). Intended Operator Profile: The SENTINEL is intended for home use. The review and analysis of data is intended for use by an appropriately trained medical practitioner.

Source page: https://510kreport.com/device/K172801
Methodology: https://510kreport.com/methodology