# K012992: Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and Cables

- Pathway: 510(k) (Special)
- Applicant: Masimo Corp.
- Decided: Oct 3, 2001 after 27 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 K944760 (1994). 2 ancestors in all.
45 later devices descend from it; 3 cite it directly.
0 of 48 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.
- K944760: Dura-Y Oxygen Transducer, Ear Clip, Nellcor, Inc. (1994) Summary page 1.

## Most influential descendants
- K111621: Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry Sensors (2011), 38 descendants of its own
- K120657: Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors (2012), 37 descendants of its own
- K150975: Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors (2015), 34 descendants of its own
- K161531: IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800 (2016), 31 descendants of its own
- K171801: IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable (2017), 8 descendants of its own

## Indications for use
The following additional Masimo Sensors are indicated for the continuous noninvasive functional oxygen saturation of arterial hemoglobin (SpO;) and pulse rate: Single use oximetry sensor intended for adults and pediatrics greater than 10 kg Reusable oximetry ear sensor intended for adults and pediatrics greater than 30 kg Reusable oximetry multisite sensor intended for adults, pediatrics, and neonates greater than 1 kg

Source page: https://510kreport.com/device/K012992
Methodology: https://510kreport.com/methodology