# K143216: Assurance Alar / Nasal SpO2 Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Xhale, Inc.
- Decided: Mar 17, 2015 after 127 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K941811 (1994). 78 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122996: Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085, Xhale (2013) Summary page 4.
- K060576: Nellcor Oximax N-600X Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2006) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- May 8, 2019 · Class II · Z-2133-2019: These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.

## Indications for use
The Assurance™ Nasal / Alar SpO2 Sensor is indicated for single patient use for continuously noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) 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 for use, under professional supervision.

Source page: https://510kreport.com/device/K143216
Methodology: https://510kreport.com/methodology