# K180407: Smartinhaler

- Pathway: 510(k) (Traditional)
- Applicant: Adherium (Nz), Ltd.
- Decided: Jul 25, 2018 after 161 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K823423 (1982). 7 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133951: Smarttouch, Nexus6, Ltd. (2014) Summary page 4.

## Most influential descendants
- K222247: Hailie Sensor NF0110 (2023), 1 descendant of its own
- K250022: HeroTracker Sense (2025), 0 descendants of its own
- K182638: Hailie Sensor (2019), 0 descendants of its own
- K182573: Hailie Sensor (2019), 0 descendants of its own

## Indications for use
The Smartinhaler™ is intended for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording actuations of prescribed MDI usage. This may be used in the following applications: ¢ In clinical trials, where researchers need to know when a patient has actuated their trial MDI medication. « In clinical practice, where specialists, general practitioners, nurses, and educators need to know if a patient has actuated their prescribed MDI medication. * In self-management, where patients need to track their medication use as part of their management plan. The Smartinhaler™ is compatible only with the following MDIs: Ventolin® HFA, Advair® HFA, Flovent® HFA, ProAir® HFA, and QVAR® HFA. The intended MDI is specified on the product labeling. The Smartinhaler™ is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.

Source page: https://510kreport.com/device/K180407
Methodology: https://510kreport.com/methodology