510(k) · Cleared
ClearedHailie Sensor NF0106
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 Jul 15, 2022 as substantially equivalent to K211233 (Adherium (Nz), Ltd., 2021) after a 134-day review. Its family tree reaches back 7 generations to 1982.
- Decided
- Jul 15, 2022
- Review
- 134 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K823423 (1982). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK823423 Nebulizer Chronolog & InterpreterAdvanced Technology Products, Inc. · 1982
- 6 generations backK970344 Mdilog, Model MDC-511Medtrak Technologies, Inc. · 1997
- 5 generations backK091803 Smarttrack SystemNexus6, Ltd. · 2009
- 4 generations backK133951 SmarttouchNexus6, Ltd. · 2014
- 3 generations backK163485 SmartTouchAdherium (Nz), Ltd. · 2017
- 2 generations backK173310 SmartTouchAdherium (Nz), Ltd. · 2018
- 1 generation backK211233 Hailie Sensor NF0109Adherium (Nz), Ltd. · 2021
- This deviceK220622 Hailie Sensor NF0106Adherium (Nz), Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K823423 | Nebulizer Chronolog & Interpreter | Advanced Technology Products, Inc. | 1982 | — |
| −6 | K970344 | Mdilog, Model MDC-511 | Medtrak Technologies, Inc. | 1997 | — |
| −5 | K091803 | Smarttrack System | Nexus6, Ltd. | 2009 | — |
| −4 | K133951 | Smarttouch | Nexus6, Ltd. | 2014 | — |
| −3 | K163485 | SmartTouch | Adherium (Nz), Ltd. | 2017 | — |
| −2 | K173310 | SmartTouch | Adherium (Nz), Ltd. | 2018 | — |
| −1 | K211233 | Hailie Sensor NF0109 | Adherium (Nz), Ltd. | 2021 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K211233 | Hailie Sensor NF0109Summary page 4…II, CAF Classification: Class II (performance standards) III. Predicate Device The predicate device to which Adherium claims substantial equivalence is: K211233 Hailie® Sensor (Model Number NF0109), manufactured by Adherium (NZ) Limited. The reference devices which support a substantial… | 2021 |
| † | K203155 | BreatheSuite MDI V1 | 2021 |
| † | K161454 | Propeller Sensor Model 2015-E | 2016 |
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 40 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K211233.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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, 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…
Read the full statement (133 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220622: Hailie Sensor NF0106.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220622
Report an extraction error
Are you the manufacturer?
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