# K121912: E1 Ear Sensors

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Jul 24, 2012 after 22 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). 69 ancestors in all.
4 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)
- K101031: Masimo Disposable Oximetry Ear Sensor, Model E1, Masimo Corporation (2010) Summary page 1.

## Most influential descendants
- 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 ElI Ear Sensor is indicated for single patient use for continuous noninvasive 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/K121912
Methodology: https://510kreport.com/methodology