# K013156: Modification to Alarmview Wireless Data Network System

- Pathway: 510(k) (Special)
- Applicant: Data Critical Corp.
- Decided: Oct 19, 2001 after 28 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
Longest line of descent: 2 generations back to K010912 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012005: Modification to Alarmview Wireless Data Network System, Data Critical Corp. (2001) Summary page 1.

## Indications for use
The AlarmView™ Wireless Data Network System is 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. The AlarmView™ System provides a secondary means of annunciating and displaying patient alarm information to mobile healthcare professionals. The AlarmView™ System 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. The AlarmView™ System is to supplement and not replace any part of the current device monitoring procedure. The AlarmView™ System is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician’s care.

Source page: https://510kreport.com/device/K013156
Methodology: https://510kreport.com/methodology