# K012005: Modification to Alarmview Wireless Data Network System

- Pathway: 510(k) (Special)
- Applicant: Data Critical Corp.
- Decided: Jul 24, 2001 after 27 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: 1 generation back to K010912 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010912: Alarmview Wireless Data Network System, Data Critical Corp. (2001) Summary page 1.

## Most influential descendants
- K013156: Modification to Alarmview Wireless Data Network System (2001), 0 descendants of its own

## 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™ Wireless Data Network System is limited to use by qualified medical professionals who have been trained on the use of the device. It is for use in hospital and hospital type environments and is not for home use. The AlarmView™ Wireless Data Network System is to supplement and not replace any part of the current device monitoring procedure. The AlarmView™ Wireless Data Network 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/K012005
Methodology: https://510kreport.com/methodology