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Smartinhaler

by Adherium (Nz), Ltd.

510(k) K180407

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK180407 Date25 Jul 2018ClearedStatusActive

Official records

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 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 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.

Similar devices

Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).

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