510(k) · Cleared
ClearedSmartinhaler
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 25, 2018 as substantially equivalent to K133951 (Nexus6, Ltd., 2014) after a 161-day review. Its family tree reaches back 4 generations to 1982. 4 later devices descend from it.
- Decided
- Jul 25, 2018
- Review
- 161 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K823423 (1982). 7 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK823423 Nebulizer Chronolog & InterpreterAdvanced Technology Products, Inc. · 1982
- 3 generations backK970344 Mdilog, Model MDC-511Medtrak Technologies, Inc. · 1997
- 2 generations backK091803 Smarttrack SystemNexus6, Ltd. · 2009
- 1 generation backK133951 SmarttouchNexus6, Ltd. · 2014
- This deviceK180407 SmartinhalerAdherium (Nz), Ltd. · 2018
- 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 ownK182638 Hailie SensorAdherium (Nz), Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK182573 Hailie SensorAdherium (Nz), Ltd. · 2019
Most influential descendants
Showing 4 of 4 · See all- K222247Hailie Sensor NF0110Adherium (Nz), Ltd. · 2023 · cites it directly1descendant
- K250022HeroTracker SenseVoluntis · 2025 · 2 generations on0descendants
- K182638Hailie SensorAdherium (Nz), Ltd. · 2019 · cites it directly0descendants
- K182573Hailie SensorAdherium (Nz), Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K823423 | Nebulizer Chronolog & Interpreter | Advanced Technology Products, Inc. | 1982 | — |
| −3 | K970344 | Mdilog, Model MDC-511 | Medtrak Technologies, Inc. | 1997 | — |
| −2 | K091803 | Smarttrack System | Nexus6, Ltd. | 2009 | — |
| −1 | K133951 | Smarttouch | Nexus6, Ltd. | 2014 | — |
| 0 (this device) | K180407 | Smartinhaler | Adherium (Nz), Ltd. | 2018 | — |
| +1 | K222247 | Hailie Sensor NF0110 | Adherium (Nz), Ltd. | 2023 | — |
| +2 | K250022 | HeroTracker Sense | Voluntis | 2025 | — |
| +1 | K182638 | Hailie Sensor | Adherium (Nz), Ltd. | 2019 | — |
| +1 | K182573 | Hailie Sensor | Adherium (Nz), Ltd. | 2019 | — |
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 |
|---|---|---|
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K133951 | 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: K133951, SmartTouch™, manufactured by Nexus6 Limited. The reference device which supports a substantial equivalence determination is: K17… | 2014 |
| † | K173310 | SmartTouch | 2018 |
What descends from it? (4)
3 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 36 years and passes through 4 companies; a new generation was cleared every 12.2 years on median.
- None of the 7 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 K133951.
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 Smartinhaler™ is intended for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording actuations of prescribed MDI usage. This may be used in the following applications: ¢ In clinical trials, where researchers need to know when a patient has actuated their trial MDI medication. « In clinical practice, where specialists, general practitioners, nurses, and educators need to know if a…
Read the full statement (144 words)
The Smartinhaler™ is intended for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording actuations of prescribed MDI usage. This may be used in the following applications:
¢ In clinical trials, where researchers need to know when a patient has actuated their trial MDI medication.
« In clinical practice, where specialists, general practitioners, nurses, and educators need to know if a patient has actuated their prescribed MDI medication.
* In self-management, where patients need to track their medication use as part of their management plan.
The Smartinhaler™ is compatible only with the following MDIs: Ventolin® HFA, Advair® HFA, Flovent® HFA, ProAir® HFA, and QVAR® HFA. The intended MDI is specified on the product labeling. The Smartinhaler™ is not intended to indicate remaining quantity of medication in an MDI 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/K180407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180407: Smartinhaler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180407
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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