# K220622: Hailie Sensor NF0106

- Pathway: 510(k) (Traditional)
- Applicant: Adherium (Nz), Ltd.
- Decided: Jul 15, 2022 after 134 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: 7 generations back to K823423 (1982). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211233: Hailie Sensor NF0109, Adherium (Nz), Ltd. (2021) Summary page 4.

## Indications for use
The Hailie@ sensor is intended for single patient, multiple use, in the home environment, as an electronic data capture accessory for monitoring and recording actuations, inspiratory flow, and inhaler orientation, 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 following ELLIPTA@ DPI inhalers: BreoTm, AnoroTm, Incrusem, Trelegym and Arnuitym. 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/K220622
Methodology: https://510kreport.com/methodology