# K090556: Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Healthcare Medical Equipment (Suzhou) CO
- Decided: Apr 30, 2009 after 59 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 70 ancestors in all.
10 later devices descend from it; 4 cite it directly.
1 of 81 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001775: Zoe Medical Nightingale Monitoring System, Zoe Medical, Inc. (2001) Summary page 2.
- K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor, Oridion Capnography, Inc. (2006) Summary page 2.
- K033296: Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V, Masimo Corp. (2004) Summary page 2.
- K062144: Escort M8 Vital Signs Patient Monitor, Model 3810, Invivo Corporation (2006) Summary page 2.
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002) Summary page 2.

## Most influential descendants
- K130740: Nightingale Monitoring System (2013), 3 descendants of its own
- K123556: Mortara Surveyor Patient Monitor (2013), 2 descendants of its own
- K161517: Mortara Surveyor Patient Monitor (2017), 1 descendant of its own
- K152043: Diagnostic Station DS20 (2016), 1 descendant of its own
- K093501: Elance Vital Signs Monitor and Elance Central Station (2009), 1 descendant of its own

## Recalls of this device
- Jul 23, 2009 · Not classified · Z-2211-2009: The Spacelabs Medical Integrated ECG Cables, PN: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25 will not withstand the high voltage of a defibrillation shock.

## Indications for use
The Spacelabs elance Vital Signs Monitor is indicated for use in patient populations for: - Adult - Pediatric The Spacelabs elance Vital Signs Monitor facilitates the monitoring of: - ECG with arrhythmia detection - Respiration - Non-invasive blood pressures - Invasive blood pressures - Body temperature - Functional arterial oxygen saturation, and - End title CO2 • The Spacelabs elance Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Source page: https://510kreport.com/device/K090556
Methodology: https://510kreport.com/methodology