# K992848: Alarmview System

- Pathway: 510(k) (Traditional)
- Applicant: Data Critical Corp.
- Decided: Nov 19, 1999 after 87 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- 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. The FDA summary names its predicate without a number.
- (no number) StatView™ System by Data Critical Corporation: named in the summary without a submission number
- (no number) TS2000 by Trincore Systems: named in the summary without a submission number
- (no number) Pager-LAN by GE Marquette Medical Systems: named in the summary without a submission number
- (no number) “Paging” by Vitalcom: named in the summary without a submission number

## Indications for use
This device is intended for use in real-time monitoring of routine patient status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. AlarmView is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital and hospital type environments and is not for home use. AlarmView is intended to supplement and not to replace any part of the current device monitoring procedures. AlarmView is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care. AlarmView is currently validated for use with the N-x9y and N-3x00 data protocols.

Source page: https://510kreport.com/device/K992848
Methodology: https://510kreport.com/methodology