# K011851: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables

- Pathway: 510(k) (Special)
- Applicant: Masimo Corp.
- Decided: Jul 11, 2001 after 28 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.
No later device cites it as a predicate yet.
0 of 2 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) Summary page 1.

## 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 (SpQy) and pulse rate (measured by an SpO, sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ 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® Radjcal Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous noninvasive monitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpQ;) and pulse rate (measured by an SpO; 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 smal) 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 I 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 SatShare™. The following are additional SatShare cables indicated for connection to the following multi-parameter monitors: Ohmeda - RGM Respiratory Monitor and Datex-Ohmeda - M-EST and M-ESTP Modlues Draeger - Vitalert 1000, 3200, Evita 4, Bvita 2 dura, Julian Anesthetic Workstation, and Narcomed 4 Monitors Airshields - Multiparameter Monitor with Ohmeda SpQ; Datascope - Passport Monitor with Datascope SpO; and Accutor Monitors with Nellcor SpO; and Datascope SpO; GE/Marquette - Tram 100A and Trams 500A modules with Ohmeda SpO,

Source page: https://510kreport.com/device/K011851
Methodology: https://510kreport.com/methodology