510(k) · Cleared
ClearedHailie Sensor
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 Dec 10, 2018 as substantially equivalent to K173310 (Adherium (Nz), Ltd., 2018) after a 195-day review. Its family tree reaches back 6 generations to 1982.
- Decided
- Dec 10, 2018
- Review
- 195 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. No later device cites it as a predicate yet.
- 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 deviceK181405 Hailie SensorAdherium (Nz), Ltd. · 2018
View 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) | K181405 | Hailie Sensor | Adherium (Nz), Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1999 | 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…esiology Devices, 21 CFR 868.5630, Class II, CAF (a)(3) Identification of Legally Marketed Devices The predicate device to which substantial equivalence is claimed is: K173310, SmartTouch™, manufactured by Adherium (NZ) Limited. The reference device which supports a substantial equivalence determination… | 2018 |
| † | K133951 | Smarttouch | 2014 |
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 36 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.
- 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. 2018, 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 a medication reminder and electronic data capture accessory for recording actuations of prescribed inhaler usage. This may be used in the following applications: * In clinical trials, where researchers need to know when a patient has actuated their trial inhaler medication. * In clinical practice, where specialists, general practitioners, nurses, and educators need to know…
Read the full statement (132 words)
The Hailie™ sensor is intended for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording actuations of prescribed inhaler usage. This may be used in the following applications:
* In clinical trials, where researchers need to know when a patient has actuated their trial inhaler medication.
* In clinical practice, where specialists, general practitioners, nurses, and educators need to know if a patient has actuated their prescribed inhaler medication.
* In self-management, where patients need to track their medication use as part of their management plan.
The Hailie™ sensor is compatible only with Bevespi Aerosphere® and is for use by adults. The Hailie™ sensor is not intended to indicate remaining quantity of medication in an inhaler and does not include a dose counting function.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181405: Hailie Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181405
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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