# K062278: Spacelabs Medical Clinical Event Interface, Model 91847

- Pathway: 510(k) (Special)
- Applicant: Spacelabs Medical, Inc.
- Decided: Sep 19, 2006 after 43 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: 4 generations back to K962827 (1997). 5 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992749: Ultraview Waveform Pager System, Model 91841, Spacelabs Medical, Inc. (2000) Summary page 3.

## Most influential descendants
- K103634: Ascom Clinicalconnex  Cardiomax (2011), 14 descendants of its own
- K130339: Clinical Alert Notification (2013), 5 descendants of its own
- K102974: Intellisphere Event Managment System Rel. 10.00 (2011), 5 descendants of its own
- K152341: ViSi Mobile Monitoring System (2015), 4 descendants of its own
- K111215: Ascom Mobile Monitoring Gateway (MMG) (2011), 3 descendants of its own

## Indications for use
The intended use of the Spacelabs Medical Clinical Event Interface is to interface with tile Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm infornation to mdbile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. The Clinical Event Interface System is intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient monitoring network. The Clinical Event Interface supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8 seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot. The Spacelabs Medical Clinical Event Interface is a secondary alarm. It does not replace the primary alarm function on the monitor.

Source page: https://510kreport.com/device/K062278
Methodology: https://510kreport.com/methodology