# K253887: Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizin Systeme
- Decided: May 1, 2026 after 148 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: 20 generations back to K941811 (1994). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171423: Nasal Alar SpO2 Sensor, Xhale, Inc. (2017) Summary page 5.

## Indications for use
The Nasal Alar SpO2 Sensor is indicated for single patient use, for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients (at least 4 years and older and weighing 215 kg), 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/K253887
Methodology: https://510kreport.com/methodology