510(k) · Cleared
ClearedAsthmapolis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reciprocal Labs Corporation · CAF Nebulizer (Direct Patient Interface)
Cleared on Jul 2, 2012 as substantially equivalent to K091803 (Nexus6, Ltd., 2009) after a 31-day review. Its family tree reaches back 3 generations to 1982. 13 later devices descend from it.
- Decided
- Jul 2, 2012
- Review
- 31 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K823423 (1982). 6 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK823423 Nebulizer Chronolog & InterpreterAdvanced Technology Products, Inc. · 1982
- 2 generations backK970344 Mdilog, Model MDC-511Medtrak Technologies, Inc. · 1997
- 1 generation backK091803 Smarttrack SystemNexus6, Ltd. · 2009
- This deviceK121609 Asthmapolis SystemReciprocal Labs Corporation · 2012
- Descendant · cites it directly · 12 of its ownK140638 Propeller System - Model 2Reciprocal Labs Corporation · 2014
- Descendant · 2 generations on · 8 of its ownK142516 Propeller SystemReciprocal Labs Corporation · 2015
- Descendant · 2 generations on · 4 of its ownK143671 Propeller Model 2014-D SensorReciprocal Labs · 2015
- Descendant · 3 generations on · 3 of its ownK152882 Propeller SystemReciprocal Labs · 2016
- Descendant · 4 generations on · 2 of its ownK161454 Propeller Sensor Model 2015-EReciprocal Labs Corporation · 2016
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K140638Propeller System - Model 2Reciprocal Labs Corporation · 2014 · cites it directly12descendants
- K142516Propeller SystemReciprocal Labs Corporation · 2015 · 2 generations on8descendants
- K143671Propeller Model 2014-D SensorReciprocal Labs · 2015 · 2 generations on4descendants
- K152882Propeller SystemReciprocal Labs · 2016 · 3 generations on3descendants
- K161454Propeller Sensor Model 2015-EReciprocal Labs Corporation · 2016 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K823423 | Nebulizer Chronolog & Interpreter | Advanced Technology Products, Inc. | 1982 | — |
| −2 | K970344 | Mdilog, Model MDC-511 | Medtrak Technologies, Inc. | 1997 | — |
| −1 | K091803 | Smarttrack System | Nexus6, Ltd. | 2009 | — |
| 0 (this device) | K121609 | Asthmapolis System | Reciprocal Labs Corporation | 2012 | — |
| +1 | K140638 | Propeller System - Model 2 | Reciprocal Labs Corporation | 2014 | — |
| +2 | K142516 | Propeller System | Reciprocal Labs Corporation | 2015 | — |
| +2 | K143671 | Propeller Model 2014-D Sensor | Reciprocal Labs | 2015 | — |
| +3 | K152882 | Propeller System | Reciprocal Labs | 2016 | — |
| +4 | K161454 | Propeller Sensor Model 2015-E | Reciprocal Labs Corporation | 2016 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K091803 | Smarttrack SystemSummary page 1…ication 21 CFR §868.5630 Regulation: Product Code: CAF Device Description: Electronic MIDI Accessory Substantially SmartTrack System K091 803 Equivalent Devices: Page 1cr 4… | 2009 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140638 | Propeller System - Model 2 | 2014 | 12 |
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 30 years and passes through 4 companies; a new generation was cleared every 12.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K140638 (Reciprocal Labs Corporation, 2014) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K091803.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Asthmapolis System includes the Asthmapolis Sensor which is an electronic accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage. The Asthmapolis Mobile Application records, stores, and transmits usage events from the Asthmapolis Sensor to a remote storage system. The Asthmapolis Web Application is software intended to allow users to review the collected…
Read the full statement (178 words)
The Asthmapolis System includes the Asthmapolis Sensor which is an electronic accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.
The Asthmapolis Mobile Application records, stores, and transmits usage events from the Asthmapolis Sensor to a remote storage system.
The Asthmapolis Web Application is software intended to allow users to review the collected information and characteristics of MDI use, to add detail associated with a recorded usage event, and to share that information with their physician in order to provide additional information associated with the condition for which their MIDI medication(s) are prescribed.
The Asthniapolis System may also be used in clinical trials where researchers need to know information about use of a MDI Medication(s) by a participant.
The output of the Asthmapolis System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Asthmapolis system is not intended for use as a MDI medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121609 · printed Nov 4, 2026
Cite this page
510(k) Report. “K121609: Asthmapolis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K121609
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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