# K071805: Netguard Automated Clinician Alert System, Model 0998-00-1600-XX

- Pathway: 510(k) (Abbreviated)
- Applicant: Datascope Corp.
- Decided: Sep 25, 2007 after 85 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K925411 (1993). 8 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021681: Micropaq, Models 402, 404, Welch Allyn Protocol, Inc. (2002) Summary page 1.
- K052160: Acuity Central Station, Model 020XXXXX (Note:  Xxxxx = Various Config.), Welch Allyn, Inc. (2005) Summary page 1.

## Most influential descendants
- K110015: Vitalsens, Aingeal, V-Pod (2011), 4 descendants of its own
- K132407: Vital Signs Patch System (in Short VSP) (2014), 1 descendant of its own
- K153275: Aingeal Activity System (2016), 0 descendants of its own
- K151835: Vital Signs Patch System (2016), 0 descendants of its own
- K151027: zensor system (2015), 0 descendants of its own

## Indications for use
The NetGuard Automated Clinician Alert System is intended for use by licensed clinicians, within a health care facility, to provide notification of life threatening cardiac events in ambulatory adult patients including: Asystole Ventricular-Fibrillation NetGuard monitors a patient's ECG and issues an alert whenever these arrhythmias are detected. The NetGuard system also provides notification for high and low heart rates.

Source page: https://510kreport.com/device/K071805
Methodology: https://510kreport.com/methodology