# K040214: Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables

- Pathway: 510(k) (Special)
- Applicant: Masimo Corp.
- Decided: Feb 25, 2004 after 26 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: 2 generations back to K000126 (2000). 2 ancestors in all.
254 later devices descend from it; 5 cite it directly.
2 of 257 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.

## Most influential descendants
- K061204: Masimo Set Radical 7 Pulse CO-Oximeter (2006), 225 descendants of its own
- K080238: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter (2008), 219 descendants of its own
- K091241: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter (2009), 155 descendants of its own
- K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter (2010), 115 descendants of its own
- K110028: Masimo Radical Y Pulse CO-Oximeter (2011), 89 descendants of its own

## Indications for use
The Masimo SET® Radical Pulse Oximeter with SatShare and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter with SatShareTM and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition the Masimo SET® Radical Pulse Oximeter with SatShareTM and accessories is indicated to provide the continuous noninvasive monitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShareTM of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multi-parameter devices for display on those devices. The Masimo LNOP® Series of Sensors are indicated for the following: A single use oximetry sensor intended for adults and pediatrics greater than 30 kg A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg A single use oximetry sensor intended for neonates with good skin integrity less than 10 kg A single use oximetry sensor intended for neonates with poor skin integrity less than 1 kg A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg A reusable oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET® Radical Pulse Oximeter with SatShareTM.

Source page: https://510kreport.com/device/K040214
Methodology: https://510kreport.com/methodology