# K093501: Elance Vital Signs Monitor and Elance Central Station

- Pathway: 510(k) (Special)
- Applicant: Spacelabs Medical, Inc.
- Decided: Nov 24, 2009 after 12 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962603 (1997). 71 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 73 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090556: Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software, Spacelabs Healthcare Medical Equipment (Suzhou) CO (2009) Summary page 1.

## Most influential descendants
- K150329: elance Vital Signs Monitor, Central Monitor Software (2015), 0 descendants of its own

## Recalls of this device
- Jul 6, 2011 · Not classified · Z-2916-2011: Model 93300 Vital Signs Monitor may stop operating while in use, and when this occurs, the monitor may also fail to power ON. The resulting situation may cause a loss of monitoring for the patient.
- Sep 23, 2010 · Not classified · Z-3024-2011: The monitor has a 3 second delay in the waveforms and respiration alarm; the delay is not disclosed in the IFU.

## Indications for use
The Spacelabs 6lance Vital Signs Monitor and 6lance Central Station is indicated for use in patient populations for: - Adult - Pediatric The Spacelabs lance Vital Signs Monitor and 61ance Central Station facilitates the monitoring of: - ECG with arrhythmia detection - Respiration - Non-invasive blood pressures - Invasive blood pressures - Body temperature - Functional arterial oxygen saturation, and - End tidal CO 2. The Spacelabs dlance Vital Signs Monitor and 6lance Central Station is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Source page: https://510kreport.com/device/K093501
Methodology: https://510kreport.com/methodology