# K182638: Hailie Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Adherium (Nz), Ltd.
- Decided: Jun 19, 2019 after 268 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: 5 generations back to K823423 (1982). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180407: Smartinhaler, Adherium (Nz), Ltd. (2018) Summary page 4.

## Indications for use
The Hailie™ sensor is intended for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording usage of prescribed inhaler medication. This may be used in the following applications: * In clinical trials, where researchers need to know when a patient has used their trial inhaler medication. * In clinical practice, where specialists, general practitioners, nurses, and educators need to know if a patient has used their prescribed inhaler medication. * In self-management, where patients need to track their medication use as part of their management plan. The Hailie™ sensor is compatible only with the HandiHaler® inhaler and is for use by adults.

Source page: https://510kreport.com/device/K182638
Methodology: https://510kreport.com/methodology