# K062397: Sentinel

- Pathway: 510(k) (Special)
- Applicant: Del Mar Reynolds Medical, Ltd.
- Decided: Jan 25, 2007 after 162 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: 2 generations back to K011345 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051960: Cardionavigator +, Del Mar Reynolds Medical, Ltd. (2005) Summary page 1.

## Most influential descendants
- K152881: Sentinel Cardiology Information Management System (2016), 0 descendants of its own

## Indications for use
Sentinel, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds Medical Monitoring products and also to act as a "control panel" for these products. It is indicated when a user wishes to consolidate the databases of his Del Mar Reynolds Medical products.

Source page: https://510kreport.com/device/K062397
Methodology: https://510kreport.com/methodology