# K040259: Masimo Set Intellivue Pulse Oximeter Module

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corp.
- Decided: Apr 22, 2004 after 78 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K941811 (1994). 56 ancestors in all.
312 later devices descend from it; 7 cite it directly.
0 of 369 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031330: Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables, Masimo Corp. (2003) Summary page 1.
- K032858: The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O., Philips Medizin Systeme Boblingen GmbH (2003) Summary page 1.

## Most influential descendants
- K050762: Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 (2005), 249 descendants of its own
- K051106: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors (2005), 247 descendants of its own
- K052801: Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 (2005), 234 descendants of its own
- K053522: Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 (2006), 233 descendants of its own
- K060221: The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors (2006), 222 descendants of its own

## Indications for use
The Masimo SET® Intellivue Pulse Oximeter Module is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SPO2) and pulse rate (measured by an SP 0 2 sensor). The Masimo SET® Intellivue Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

Source page: https://510kreport.com/device/K040259
Methodology: https://510kreport.com/methodology