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Assurance Alar Sensor Model 10078; Ab-n Adapter Cable Model 10085

by Xhale

510(k) K122996

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK122996 Date10 Apr 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 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 Sensor Model 10078 and Ab-n Adapter Cable Model 10085 are medical devices designed to monitor oxygen saturation levels in patients. The Alar Sensor terminates in a DB-9 connector compatible with monitors using Nellcor OxiSensor II SpO2 technology, such as the Nellcor N-395.

These devices are supplied as single-use items and are intended for use in clinical settings. They are not reusable and must be disposed of after use. The devices are not MRI safe and should be stored in a dry, cool place away from direct sunlight. The product is authorized under FDA 510(k) clearance with the K number K122996.

Other devices from Xhale, Inc.

Questions

AI-generated answers, 25 Sep 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 Sensor Model 10078 used for?

    The Assurance Alar Sensor Model 10078 is designed to monitor oxygen saturation levels in patients. It terminates in a DB-9 connector compatible with monitors using Nellcor OxiSensor II SpO2 technology, such as the Nellcor N-395.

  • Is the Assurance Alar Sensor reusable or single-use?

    The Assurance Alar Sensor and Ab-n Adapter Cable are supplied as single-use items and are not reusable. They must be disposed of after use to ensure patient safety and maintain device accuracy.

  • What are the storage requirements for these devices?

    The devices should be stored in a dry, cool place away from direct sunlight. Proper storage conditions help maintain the integrity and functionality of the sensors until use.

  • Are these devices MRI safe?

    No, the Assurance Alar Sensor Model 10078 and Ab-n Adapter Cable Model 10085 are not MRI safe. They should not be used in MRI environments as this could affect their performance or pose safety risks.