# K211233: Hailie Sensor NF0109

- Pathway: 510(k) (Traditional)
- Applicant: Adherium (Nz), Ltd.
- Decided: Aug 18, 2021 after 117 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: 6 generations back to K823423 (1982). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173310: SmartTouch, Adherium (Nz), Ltd. (2018) 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
- K220622: Hailie Sensor NF0106 (2022), 0 descendants of its own

## Indications for use
The Hailie® sensor is intended for single-patient use in the home environment as an electronic data capture accessory for monitoring and recording actuations, inspiratory flow, and inhaler shake, for prescribed inhaler usage. The Hailie® sensor may be used in the following applications: in clinical practice or clinical trials, where specialists, general practitioners, nurses, and educators need to know if a patient has used their prescribed medication, or assess inspiratory flow and inhaler technique; and in patient self-management including medication reminders. The Hailie® sensor is compatible only with the Symbicort™ MDI inhaler. The Hailie® sensor is not intended to indicate remaining quantity of medication in an inhaler and does not include a dose counting function. The Hailie® sensor is not intended to provide spirometry measurements.

Source page: https://510kreport.com/device/K211233
Methodology: https://510kreport.com/methodology