510(k) · Cleared
ClearedSmarttrack System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexus6, Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Oct 9, 2009 as substantially equivalent to K990185 (Medtrak Technologies, Inc., 1999) and 2 other predicates after a 115-day review. Its family tree reaches back 2 generations to 1982. 25 later devices descend from it.
- Decided
- Oct 9, 2009
- Review
- 115 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K823423 (1982). 5 ancestors in all. 25 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK823423 Nebulizer Chronolog & InterpreterAdvanced Technology Products, Inc. · 1982
- 1 generation backK970344 Mdilog, Model MDC-511Medtrak Technologies, Inc. · 1997
- This deviceK091803 Smarttrack SystemNexus6, Ltd. · 2009
- Descendant · cites it directly · 13 of its ownK121609 Asthmapolis SystemReciprocal Labs Corporation · 2012
- Descendant · 2 generations on · 12 of its ownK140638 Propeller System - Model 2Reciprocal Labs Corporation · 2014
- Descendant · cites it directly · 10 of its ownK133951 SmarttouchNexus6, Ltd. · 2014
- Descendant · 3 generations on · 8 of its ownK142516 Propeller SystemReciprocal Labs Corporation · 2015
- Descendant · 2 generations on · 6 of its ownK163485 SmartTouchAdherium (Nz), Ltd. · 2017
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K121609Asthmapolis SystemReciprocal Labs Corporation · 2012 · cites it directly13descendants
- K140638Propeller System - Model 2Reciprocal Labs Corporation · 2014 · 2 generations on12descendants
- K133951SmarttouchNexus6, Ltd. · 2014 · cites it directly10descendants
- K142516Propeller SystemReciprocal Labs Corporation · 2015 · 3 generations on8descendants
- K163485SmartTouchAdherium (Nz), Ltd. · 2017 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K823423 | Nebulizer Chronolog & Interpreter | Advanced Technology Products, Inc. | 1982 | — |
| −1 | K970344 | Mdilog, Model MDC-511 | Medtrak Technologies, Inc. | 1997 | — |
| 0 (this device) | K091803 | Smarttrack System | Nexus6, Ltd. | 2009 | — |
| +1 | K121609 | Asthmapolis System | Reciprocal Labs Corporation | 2012 | — |
| +2 | K140638 | Propeller System - Model 2 | Reciprocal Labs Corporation | 2014 | — |
| +1 | K133951 | Smarttouch | Nexus6, Ltd. | 2014 | — |
| +3 | K142516 | Propeller System | Reciprocal Labs Corporation | 2015 | — |
| +2 | K163485 | SmartTouch | Adherium (Nz), Ltd. | 2017 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K990185 | Mdilog, Model MDC-512Summary page 1…lizer (Direct Patient Interface) Anesthesiology Devices, 21 CFR §868.5630, Class II, CAF (a)(3) Identification of Legally Marketed Devices K990185 MDILog Model MDC-512 Medtrac Technologies Inc K970344 MDILog Model MDC-511 Medtrac… | 1999 |
| * | K970344 | Mdilog, Model MDC-511Summary page 1…Devices, 21 CFR §868.5630, Class II, CAF (a)(3) Identification of Legally Marketed Devices K990185 MDILog Model MDC-512 Medtrac Technologies Inc K970344 MDILog Model MDC-511 Medtrac Technologies Inc K935955 Doser MDI Counter Newmed C… | 1997 |
| * | K935955 | DOSERSummary page 1…rketed Devices K990185 MDILog Model MDC-512 Medtrac Technologies Inc K970344 MDILog Model MDC-511 Medtrac Technologies Inc K935955 Doser MDI Counter Newmed Corporation (a)(4) Description of the Device The SmartTrack System consists… | 1994 |
What descends from it? (25)
See all 252 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 27 years and passes through 3 companies; a new generation was cleared every 14.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K121609 (Reciprocal Labs Corporation, 2012) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K990185.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 SmartTrack System is intended for single-patient use as an electronic data capture accessory for recording and monitoring 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, and nurse educators need to know if a patient has actuated their prescribed MDI medication.
The SmartTrack is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091803 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091803: Smarttrack System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091803
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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