510(k) · Cleared
ClearedHailie Sensor NF0109
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adherium (Nz), Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Aug 18, 2021 as substantially equivalent to K173310 (Adherium (Nz), Ltd., 2018) after a 117-day review. Its family tree reaches back 6 generations to 1982. 3 later devices descend from it.
- Decided
- Aug 18, 2021
- Review
- 117 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K823423 (1982). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK823423 Nebulizer Chronolog & InterpreterAdvanced Technology Products, Inc. · 1982
- 5 generations backK970344 Mdilog, Model MDC-511Medtrak Technologies, Inc. · 1997
- 4 generations backK091803 Smarttrack SystemNexus6, Ltd. · 2009
- 3 generations backK133951 SmarttouchNexus6, Ltd. · 2014
- 2 generations backK163485 SmartTouchAdherium (Nz), Ltd. · 2017
- 1 generation backK173310 SmartTouchAdherium (Nz), Ltd. · 2018
- This deviceK211233 Hailie Sensor NF0109Adherium (Nz), Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK222247 Hailie Sensor NF0110Adherium (Nz), Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK250022 HeroTracker SenseVoluntis · 2025
- Descendant · cites it directly · 0 of its ownK220622 Hailie Sensor NF0106Adherium (Nz), Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K823423 | Nebulizer Chronolog & Interpreter | Advanced Technology Products, Inc. | 1982 | — |
| −5 | K970344 | Mdilog, Model MDC-511 | Medtrak Technologies, Inc. | 1997 | — |
| −4 | K091803 | Smarttrack System | Nexus6, Ltd. | 2009 | — |
| −3 | K133951 | Smarttouch | Nexus6, Ltd. | 2014 | — |
| −2 | K163485 | SmartTouch | Adherium (Nz), Ltd. | 2017 | — |
| −1 | K173310 | SmartTouch | Adherium (Nz), Ltd. | 2018 | — |
| 0 (this device) | K211233 | Hailie Sensor NF0109 | Adherium (Nz), Ltd. | 2021 | — |
| +1 | K222247 | Hailie Sensor NF0110 | Adherium (Nz), Ltd. | 2023 | — |
| +2 | K250022 | HeroTracker Sense | Voluntis | 2025 | — |
| +1 | K220622 | Hailie Sensor NF0106 | Adherium (Nz), Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K173310 | SmartTouchSummary page 4…Anesthesiology Devices, 21 CFR 868.5630, Class II, CAF III. Predicate Device The predicate device to which substantial equivalence claimed is: K173310 SmartTouch, manufactured by Adherium (NZ) Limited. The reference devices which support a substantial equivalence determination ar… | 2018 |
| † | K183586 | CapMedic | 2019 |
| † | K181405 | Hailie Sensor | 2018 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 39 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K222247 (Adherium (Nz), Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K173310.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 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…
Read the full statement (124 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211233: Hailie Sensor NF0109.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211233
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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