510(k) · Cleared
ClearedHeroTracker Sense
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voluntis · CAF Nebulizer (Direct Patient Interface)
Cleared on Jun 30, 2025 as substantially equivalent to K222247 (Adherium (Nz), Ltd., 2023) after a 178-day review. Its family tree reaches back 8 generations to 1982.
- Decided
- Jun 30, 2025
- Review
- 178 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K823423 (1982). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK823423 Nebulizer Chronolog & InterpreterAdvanced Technology Products, Inc. · 1982
- 7 generations backK970344 Mdilog, Model MDC-511Medtrak Technologies, Inc. · 1997
- 6 generations backK091803 Smarttrack SystemNexus6, Ltd. · 2009
- 5 generations backK133951 SmarttouchNexus6, Ltd. · 2014
- 4 generations backK163485 SmartTouchAdherium (Nz), Ltd. · 2017
- 3 generations backK173310 SmartTouchAdherium (Nz), Ltd. · 2018
- 2 generations backK211233 Hailie Sensor NF0109Adherium (Nz), Ltd. · 2021
- 1 generation backK222247 Hailie Sensor NF0110Adherium (Nz), Ltd. · 2023
- This deviceK250022 HeroTracker SenseVoluntis · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K823423 | Nebulizer Chronolog & Interpreter | Advanced Technology Products, Inc. | 1982 | — |
| −7 | K970344 | Mdilog, Model MDC-511 | Medtrak Technologies, Inc. | 1997 | — |
| −6 | K091803 | Smarttrack System | Nexus6, Ltd. | 2009 | — |
| −5 | K133951 | Smarttouch | Nexus6, Ltd. | 2014 | — |
| −4 | K163485 | SmartTouch | Adherium (Nz), Ltd. | 2017 | — |
| −3 | K173310 | SmartTouch | Adherium (Nz), Ltd. | 2018 | — |
| −2 | K211233 | Hailie Sensor NF0109 | Adherium (Nz), Ltd. | 2021 | — |
| −1 | K222247 | Hailie Sensor NF0110 | Adherium (Nz), Ltd. | 2023 | — |
| 0 (this device) | K250022 | HeroTracker Sense | Voluntis | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1999 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAF device
- #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K222247 | Hailie Sensor NF0110Summary page 5…Class 2 Classification Panel: Anesthesiology 5. Legally Marketed Predicate Device(s) Device name: Hailie® Sensor NF0110 510(k) number: K222247 Manufacturer: Adherium (NZ) Ltd Page 1 of 7 K250022… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 43 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · CAF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAF
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAF
1in 2018
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · CAF
191in 2025
MAUDE reports naming product code CAF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 98 | 1 | 26 |
| 2008 | 12 | 123 | 0 | 11 |
| 2009 | 8 | 163 | 0 | 15 |
| 2010 | 10 | 114 | 0 | 37 |
| 2011 | 10 | 157 | 1 | 237 |
| 2012 | 9 | 126 | 0 | 138 |
| 2013 | 9 | 238 | 0 | 217 |
| 2014 | 9 | 151 | 5 | 123 |
| 2015 | 8 | 186 | 3 | 166 |
| 2016 | 5 | 186 | 1 | 201 |
| 2017 | 8 | 253 | 14 (13) | 256 |
| 2018 | 9 | 161 | 1 | 162 |
| 2019 | 3 | 266 | 0 | 185 |
| 2020 | 6 | 219 | 0 | 117 |
| 2021 | 8 | 324 | 0 | 161 |
| 2022 | 4 | 176 | 0 | 55 |
| 2023 | 8 | 279 | 0 | 107 |
| 2024 | 4 | 251 | 0 | 102 |
| 2025 | 7 | 211 | 0 | 191 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (239 words)
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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250022: HeroTracker Sense.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250022
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026