# K101031: Masimo Disposable Oximetry Ear Sensor, Model E1

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Nov 18, 2010 after 219 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: 15 generations back to K941811 (1994). 68 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012992: Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and Cables, Masimo Corp. (2001) Summary page 1.
- K051212: Modification to LNCS Oximetry Sensors, Masimo Corporation (2005) Summary page 1.

## Most influential descendants
- K121912: E1 Ear Sensors (2012), 4 descendants of its own
- K122996: Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085 (2013), 3 descendants of its own
- K143216: Assurance Alar / Nasal SpO2 Sensor (2015), 2 descendants of its own
- K171423: Nasal Alar SpO2 Sensor (2017), 1 descendant of its own
- K253887: Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) (2026), 0 descendants of its own

## Indications for use
The Masimo Disposable Ear Sensors are indicated for single patient use for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SPo2 sensor) for use with adult and pediatric patients, (weighing >30kg), who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K101031
Methodology: https://510kreport.com/methodology