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Ochsner Connected Inhaler Sensor

by Ochsner Clinic Foundation

510(k) K223367

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 NumberK223367 Date30 Aug 2023ClearedStatusActive

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  • Withdrawn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
CAF
Device Class
Class II
Regulation
21 CFR Part 868.5630
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Ochsner Connected Inhaler Sensor is a device designed to monitor and record inhalation events from a metered-dose inhaler. It connects wirelessly to a mobile application to track medication usage and adherence.

The device is supplied as a reusable sensor that attaches to compatible inhalers. It is intended for use in home and clinical settings to support respiratory therapy management. The device has received FDA 510(k) clearance (K223367) and is manufactured by Ochsner Clinic Foundation in New Orleans, Louisiana.

Questions

AI-generated answers, 1 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 Ochsner Connected Inhaler Sensor used for?

    The Ochsner Connected Inhaler Sensor is designed to monitor and record inhalation events from a metered-dose inhaler, helping track medication usage and adherence by wirelessly connecting to a mobile application for respiratory therapy management in home and clinical settings.

  • How is the Ochsner Connected Inhaler Sensor supplied and is it reusable?

    The device is supplied as a reusable sensor that attaches to compatible metered-dose inhalers, allowing multiple uses after proper cleaning and maintenance as intended for ongoing monitoring of inhalation events.

  • Does the Ochsner Connected Inhaler Sensor require sterilization before use?

    The device is supplied as a reusable sensor and does not require sterilization; it is intended for attachment to compatible inhalers and should be cleaned according to manufacturer guidelines for repeated use in home or clinical environments.

  • What regulatory clearance does the Ochsner Connected Inhaler Sensor have?

    The Ochsner Connected Inhaler Sensor has received FDA 510(k) clearance under submission number K223367, indicating it was found substantially equivalent to a legally marketed predicate device.