# K150329: elance Vital Signs Monitor, Central Monitor Software

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Healthcare
- Decided: Nov 5, 2015 after 268 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K962603 (1997). 72 ancestors in all.
No later device cites it as a predicate yet.
1 of 73 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093501: Elance Vital Signs Monitor and Elance Central Station, Spacelabs Medical, Inc. (2009) Summary page 4.
- K033296: Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V, Masimo Corp. (2004) Summary page 4.
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002) Summary page 4.

## Indications for use
The Spacelabs élance Vital Signs Monitor and élance Central Station is indicated for use in patient populations for: - Adult - Pediatric (1 year old and above) The Spacelabs élance Vital Signs Monitor and élance 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 CO2. The Spacelabs élance Vital Signs Monitor and élance 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/K150329
Methodology: https://510kreport.com/methodology