# K250022: HeroTracker Sense

- Pathway: 510(k) (Traditional)
- Applicant: Voluntis
- Decided: Jun 30, 2025 after 178 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: 8 generations back to K823423 (1982). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222247: Hailie Sensor NF0110, Adherium (Nz), Ltd. (2023) Summary page 5.

## Indications for use
The HeroTracker Sense Device (HTS) is an add-on device which is attached by patients on a metered-dose inhaler (MDI). HTS is intended for single-patient multiple use in the home environment as an electronic data capture accessory for monitoring and recording actuation, inhaler shake, inhaler orientation, inhalation coordination, and inspiratory strength and duration for prescribed inhaler usage. HTS 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 inhaler technique. HTS is designed to work only with the MDI and medication indicated on the HTS label. HTS is not intended to indicate the remaining quantity of medication in an inhaler and does not include a dose counting function. HTS is not intended to provide spirometry measurements. HTS is intended to be used by Metered Dose Inhaler (MDI) users aged 12 years and over. Compatible Medication - Strength and Dose Account Ventolin 90 mcg HFA (60 count) Advair 45 mcg / 21 mcg (120 count) Advair 115 mcg / 21 mcg (120 count) Advair 230 mcg / 21 mcg (120 count) Albuterol Sulfate (Prasco) 90 mcg (200 count) Fluticasone Propionate & Salmeterol 45 mcg / 21 mcg (120 count) Fluticasone Propionate & Salmeterol 115 mcg / 21 mcg (120 count) Fluticasone Propionate & Salmeterol 230 mcg / 21 mcg (120 count) Albuterol Sulfate (Lupin) 90 mcg (200 count)

Source page: https://510kreport.com/device/K250022
Methodology: https://510kreport.com/methodology