# K122996: Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085

- Pathway: 510(k) (Traditional)
- Applicant: Xhale
- Decided: Apr 10, 2013 after 195 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: 17 generations back to K941811 (1994). 75 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K021089: Oximax Max-Fast Adhesive Forehead Sensor, Nellcor Puritan Bennett, Inc. (2002) Summary page 1.
- K121912: E1 Ear Sensors, Masimo Corporation (2012) Summary page 1.

## Most influential descendants
- 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 Assurance Alar Sensor is indicated for single patient use for continuously noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (5P02) and pulse rate from the nasal ala of adult and pediatric patients (weighing > 30kg), who are well or poorly perfused. The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated far use, under professional supervision.

Source page: https://510kreport.com/device/K122996
Methodology: https://510kreport.com/methodology