# K031330: Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables

- Pathway: 510(k) (Special)
- Applicant: Masimo Corp.
- Decided: May 12, 2003 after 14 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: 1 generation back to K000126 (2000). 1 ancestor in all.
519 later devices descend from it; 14 cite it directly.
8 of 521 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000126: Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric Disposable Sensor, Masimo Lno-PDT-Pedia, Masimo Corp. (2000)

## Most influential descendants
- K040259: Masimo Set Intellivue Pulse Oximeter Module (2004), 312 descendants of its own
- K033296: Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V (2004), 279 descendants of its own
- K040214: Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables (2004), 254 descendants of its own
- 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

## Indications for use
The Masimo SET@Radical Pulse Oximeter with SatShareTM and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (measured by an Sp02 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 SatShareThland 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 (SpOz) and pulse rate (measured by an Sp02 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/K031330
Methodology: https://510kreport.com/methodology