# K111621: Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Oct 26, 2011 after 138 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: 16 generations back to K941811 (1994). 80 ancestors in all.
38 later devices descend from it; 1 cites it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100617: Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20D, Masimo Corporation (2010) Summary page 1.
- K012992: Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and Cables, Masimo Corp. (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K100896: Gyrus Acmi Halo PKS Cutting Forceps, Gyrus Acmi, Inc. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K221704: HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) (2022), 6 descendants of its own

## Indications for use
The ReSposable SP02 Series is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2) and pulse rate (measured by an SP02 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile and home environments.

Source page: https://510kreport.com/device/K111621
Methodology: https://510kreport.com/methodology