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Assurance Alar / Nasal SpO2 Sensor

by Xhale, Inc.

510(k) K143216

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK143216 Date17 Mar 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2133-2019 FDA Class II initiated 8 May 2019

    These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Assurance Alar / Nasal SpO2 Sensor is a device for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala. It is designed for use on adult and pediatric patients weighing over 30kg. The sensor provides fast and accurate SpO2 readings and is intended for single patient use.

The Assurance Alar / Nasal SpO2 Sensor is supplied for single-use and is designed to stay in place on the nasal ala without adhesive. It has received FDA 510K authorization and has a product code of DQA. The device is available in a standard size and may require shipping time from the facility.

Other devices from Xhale, Inc.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Assurance Alar Nasal SpO2 Sensor used for?

    The Assurance Alar Nasal SpO2 Sensor is used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate from the nasal ala in adult and pediatric patients weighing over 30kg.

  • Is the Assurance Alar Nasal SpO2 Sensor reusable?

    No, the Assurance Alar Nasal SpO2 Sensor is designed for single patient use and is supplied for single-use.

  • How is the Assurance Alar Nasal SpO2 Sensor secured in place?

    The sensor is designed to stay in place on the nasal ala without adhesive.