510(k) · Cleared
ClearedPropeller System - Model 2
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 May 2, 2014 as substantially equivalent to K121609 (Reciprocal Labs Corporation, 2012) after a 51-day review. Its family tree reaches back 4 generations to 1982. 12 later devices descend from it.
- Decided
- May 2, 2014
- Review
- 51 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. 12 later devices descend from it, 4 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 backK121609 Asthmapolis SystemReciprocal Labs Corporation · 2012
- This deviceK140638 Propeller System - Model 2Reciprocal Labs Corporation · 2014
- Descendant · cites it directly · 8 of its ownK142516 Propeller SystemReciprocal Labs Corporation · 2015
- Descendant · cites it directly · 4 of its ownK143671 Propeller Model 2014-D SensorReciprocal Labs · 2015
- Descendant · 2 generations on · 3 of its ownK152882 Propeller SystemReciprocal Labs · 2016
- Descendant · 3 generations on · 2 of its ownK161454 Propeller Sensor Model 2015-EReciprocal Labs Corporation · 2016
- Descendant · 2 generations on · 1 of its ownK223367 Ochsner Connected Inhaler SensorOchsner Clinic Foundation · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K142516Propeller SystemReciprocal Labs Corporation · 2015 · cites it directly8descendants
- K143671Propeller Model 2014-D SensorReciprocal Labs · 2015 · cites it directly4descendants
- K152882Propeller SystemReciprocal Labs · 2016 · 2 generations on3descendants
- K161454Propeller Sensor Model 2015-EReciprocal Labs Corporation · 2016 · 3 generations on2descendants
- K223367Ochsner Connected Inhaler SensorOchsner Clinic Foundation · 2023 · 2 generations on1descendant
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 | K121609 | Asthmapolis System | Reciprocal Labs Corporation | 2012 | — |
| 0 (this device) | K140638 | Propeller System - Model 2 | Reciprocal Labs Corporation | 2014 | — |
| +1 | K142516 | Propeller System | Reciprocal Labs Corporation | 2015 | — |
| +1 | K143671 | Propeller Model 2014-D Sensor | Reciprocal Labs | 2015 | — |
| +2 | K152882 | Propeller System | Reciprocal Labs | 2016 | — |
| +3 | K161454 | Propeller Sensor Model 2015-E | Reciprocal Labs Corporation | 2016 | — |
| +2 | K223367 | Ochsner Connected Inhaler Sensor | Ochsner Clinic Foundation | 2023 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K121609 | Asthmapolis SystemSummary page 1…21 CFR §868.5630 Regulation: Product Code: CAF Device Description: Electronic MDI Accessory Substantially Equivalent Devices: Asthmapolis Ki121609 Page 1 of5 510(k) Premarket… | 2012 |
What descends from it? (12)
See all 124 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 32 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, K142516 (Reciprocal Labs Corporation, 2015) has gone furthest, with 8 descendants of its own.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Propeller System includes the Propeller MDI Model 2 Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage. The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage systemn. With the Propeller Mobile Application the user can review information…
Read the full statement (352 words)
The Propeller System includes the Propeller MDI Model 2 Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage. The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage systemn. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers.
The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their MDI and its use, to Capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and health care providers.
When used under the care of a physician with a prescribed MIDI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing MIDI technique. When used under the care of a physician with a prescribed MDI, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI medications through the use of feedback such as reminders and notifications, and self-management education.
The Propeller System is intended to be used in populations from Used in populations from Child (>2 years) to adult.
The Propeller system can be used both indoors and outdoors; home, work and clinical settings, as well as on aircraft.
The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI medication(s) by a participant. The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Propeller System is not intended for use as an MDI 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/K140638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140638: Propeller System - Model 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140638
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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