# K152881: Sentinel Cardiology Information Management System

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Healthcare, Ltd.
- Decided: Apr 1, 2016 after 184 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K842308 (1984). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062397: Sentinel, Del Mar Reynolds Medical, Ltd. (2007) Summary page 5.
- K130155: Muse Cardiology Information System, Ge Medical Systems Information Technologies, Inc. (2013) Summary page 5.

## Recalls of this device
- Sep 16, 2025 · Class II · Z-0416-2026: Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, un
- Nov 6, 2020 · Class II · Z-0563-2021: During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time of the upgrade, may have unrelated comme

## Indications for use
The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and to manage patient and facility information. The Sentinel Cardiology Information Management System provides download and storage of data from supported Holter recorders and feeds this data to separate and optional Holter analyzers. The completed reports are stored back in Sentinel. The Sentinel Cardiology Information Management System facilitates presenting, analyzing, reviewing cardiovascular information, including automatic interpretation of 12 lead ECG and stores the finished reports. The automatic interpretation of 12-lead ECG is not suitable for neonates. Sentinel supports importing reports from external systems and provides an HL7 interface to external systems. The Sentinel Cardiology Information Management System is intended to be used by a trained user and as an aid to a medical professional in hospital or primary care environment. The Sentinel Cardiology Information Management System is not intended for patient monitoring.

Source page: https://510kreport.com/device/K152881
Methodology: https://510kreport.com/methodology