# K990378: Statview System

- Pathway: 510(k) (Traditional)
- Applicant: Data Critical Corp.
- Decided: Sep 20, 1999 after 224 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 (previously cleared): named in the summary without a submission number
- (no number) Pager-LAN: named in the summary without a submission number
- (no number) Palm Vue (M1490A): named in the summary without a submission number
- (no number) “Paging”: named in the summary without a submission number

## Most influential descendants
- K112282: M Visum Alert Alarm Management System (2011), 0 descendants of its own

## Indications for use
This device is indicated for use in real-time monitoring of routine patient status and alarm events. StatView is limited to use by qualified medical professionals who have been trained on the use of the device. StatView is not intended for home use. StatView™ is a paging system that interfaces with primary patient monitoring systems (PPMS) to serve 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. StatView™ has been validated for use with the following networks: Héwlett-Packard CareNet, GE Marquette Medical Unity, and Siemens Medical Systems Infinity.

Source page: https://510kreport.com/device/K990378
Methodology: https://510kreport.com/methodology