Identifiers
- 510(k) Number
- K180407 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 Smartinhaler is a digital inhaler device designed to monitor and track patient usage of inhaled medications. Classified as a nebulizer with a direct patient interface, it integrates sensor technology to provide real-time feedback on medication adherence, supporting the management of respiratory conditions such as asthma and COPD.
Supplied as a reusable device with FDA 510(k) clearance (K180407), the Smartinhaler connects to a cloud-based platform for remote monitoring. It is intended for use in clinical and home settings, requiring no additional sterility measures beyond standard inhaler hygiene. The device’s sensor functionality relies on compatibility with specific inhaler medications and does not alter medication delivery.
Frequently asked questions
Is the Smartinhaler designed for single-use or can it be reused over time?
The Smartinhaler is explicitly described as a reusable device, meaning it is intended for long-term use by individual patients. Since it does not require additional sterility measures beyond standard inhaler hygiene, it can be cleaned and reused with compatible inhaler medications. This design aligns with its purpose as a monitoring tool rather than a consumable item.
How does the Smartinhaler track medication adherence, and what respiratory conditions does it support?
The Smartinhaler uses sensor technology integrated into the device to monitor and record when a patient uses their inhaler. While it does not alter medication delivery, it provides real-time feedback via a connected cloud-based platform. This data helps clinicians manage respiratory conditions like asthma and COPD, though the device itself does not specify a direct clinical indication—it simply supports adherence tracking for these conditions in both clinical and home settings.
Does the Smartinhaler require special cleaning or sterility measures beyond standard inhaler hygiene?
No, the Smartinhaler does not mandate additional sterility measures beyond what is typically recommended for standard inhaler devices. Since it is reusable and designed for home or clinical use, patients should follow general inhaler hygiene practices (e.g., cleaning with mild soap and water) to maintain functionality and prevent contamination. The device’s sensor functionality remains unaffected by these standard cleaning procedures.
What types of inhaler medications is the Smartinhaler compatible with, and how does it connect to monitoring systems?
The Smartinhaler’s sensor technology is compatible only with specific inhaler medications, though the exact list is not provided in the data. It connects to a cloud-based platform for remote monitoring, enabling healthcare providers to track usage patterns without altering the medication’s delivery. This digital integration is key to its adherence-monitoring capabilities, but compatibility depends on the inhaler’s design and the device’s built-in sensors.
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, Adherium - About, K180407 - Smartinhaler | FDA 510(k) | Adherium (Nz), Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180407 | Class II | Active |
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Manufacturer
- Manufacturer
- Adherium (Nz), Ltd.
Sources (1)
- FDA 510(k) K180407 24 fields · synced Sep 19, 2026