Identifiers
- 510(k) Number
- K182573 FDA 510(k)
- FDA Product Code
- CAF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5630 FDA 510(k)
- Regulation Number
- 868.5630 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hailie Sensor is an electronic data capture accessory designed for monitoring and recording actuations, inspiratory flow, and inhaler usage. It is intended for single patient, multiple use in the home environment. This device helps track inhaler usage for patients with asthma or COPD.
The Hailie Sensor is supplied as a reusable device for home use and is not specified as MRI safe. It is authorized under FDA 510K clearance with product code CAF and K-number K182573. The device is manufactured by Adherium (NZ), Ltd. in Auckland, New Zealand.
Frequently asked questions
What is the Hailie Sensor used for?
The Hailie Sensor is an electronic data capture accessory designed for monitoring and recording actuations, inspiratory flow, and inhaler usage. It helps track inhaler usage for patients with asthma or COPD in the home environment.
Is the Hailie Sensor a single-use or reusable device?
The Hailie Sensor is supplied as a reusable device for single patient, multiple use in the home environment. It is not specified as MRI safe.
What is the regulatory status of the Hailie Sensor?
The Hailie Sensor is authorized under FDA 510K clearance with product code CAF and K-number K182573. It was manufactured by Adherium (NZ), Ltd. and received clearance on June 7, 2019.
How is the Hailie Sensor supplied?
The Hailie Sensor is supplied as a reusable device for home use. It is not specified as MRI safe and is intended for single patient, multiple use in the home environment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Adherium - Adherium, The Hailie™ Solution Helps Patients Track Their Inhaler Usage, PDF Adherium (NZ) Ltd Tara M. Creaven-Capasso Vice President Quality ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182573 | Class II | Active |
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Manufacturer
- Manufacturer
- Adherium (Nz), Ltd.
Sources (1)
- FDA 510(k) K182573 24 fields · synced Sep 24, 2026