510(k) · Cleared
ClearedFindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FindAir Sp. z o.o. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jun 2, 2026 as substantially equivalent to K223367 (Ochsner Clinic Foundation, 2023) after a 125-day review. Its family tree reaches back 7 generations to 1982.
- Decided
- Jun 2, 2026
- Review
- 125 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 backK121609 Asthmapolis SystemReciprocal Labs Corporation · 2012
- 3 generations backK140638 Propeller System - Model 2Reciprocal Labs Corporation · 2014
- 2 generations backK142516 Propeller SystemReciprocal Labs Corporation · 2015
- 1 generation backK223367 Ochsner Connected Inhaler SensorOchsner Clinic Foundation · 2023
- This deviceK260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o. · 2026
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 | K121609 | Asthmapolis System | Reciprocal Labs Corporation | 2012 | — |
| −3 | K140638 | Propeller System - Model 2 | Reciprocal Labs Corporation | 2014 | — |
| −2 | K142516 | Propeller System | Reciprocal Labs Corporation | 2015 | — |
| −1 | K223367 | Ochsner Connected Inhaler Sensor | Ochsner Clinic Foundation | 2023 | — |
| 0 (this device) | K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. z o.o. | 2026 | — |
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 K254171 Mesh Nebulizer (UN204); Mesh Nebulizer…score 13.2 · 5 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 |
|---|---|---|---|
| * | K223367 | Ochsner Connected Inhaler SensorSummary page 5…630 Product Code: CAF - Nebulizer (Direct Patient Interface) Device Class: Class II Classification Panel: Anesthesiology 5. Legally Marketed Predicate Device K223367, Ochsner Connected Inhaler Sensor, Ochsner Clinic Foundation, New Orleans, LA, USA 6. Device Description The FindAir ONE for p… | 2023 |
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 44 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 purpose of FindAir ONE for pMDI FOMDI10 is to collect information on the use of the pMDI to support the inhalation therapy of targeted respiratory diseases. The product is aimed at patients and professionals (physicians, researchers) who wish to collect data on the use of inhalers. The FindAir ONE for pMDI FOMDI10 may also be used to send data to remote therapeutic monitoring systems (RTM). The product is intended for adult patients and people under…
Read the full statement (369 words)
The purpose of FindAir ONE for pMDI FOMDI10 is to collect information on the use of the pMDI to support
the inhalation therapy of targeted respiratory diseases. The product is aimed at patients and professionals
(physicians, researchers) who wish to collect data on the use of inhalers. The FindAir ONE for pMDI
FOMDI10 may also be used to send data to remote therapeutic monitoring systems (RTM).
The product is intended for adult patients and people under adult care (both children older than 2 years of
age and adults requiring supervision). The product is intended for multiple use by single user. Up to 127
uses of the inhaler can be recorded and stored in FindAir ONE for pMDI FOMDI10.
FindAir ONE for pMDI FOMDI10 can be used in indoor and outdoor settings such as at home, at work, in
the environment of specialist clinics, etc.
The product is not intended for diagnosis or treatment and does not replace diagnosis by a doctor or
treatment prescribed by a doctor.
The FindAir ONE for pMDI FOMDI10 device complies with the requirements of IEC 60601-1 as a product
with a type BF applied part.
The app, FindAir Viewer, is designed for iOS and Android (mobile only), enabling:
- Connection to the FindAir ONE for pMDI FOMDI10 device
- Reading data from the FindAir ONE for FOMDI10 devices (battery status, number of stored events, total
number of clicks, total operating time, MAC address).
- Presentation of this data in an easy-to-read form to the user.
- Warning of low battery status
- Transmits usage events from device
The FindAir Viewer application will be made available to users via the Apple App Store and Google Play, It
is intended to be used exclusively with the FindAir ONE for pMDI FOMDI10 device and is provided to
customers as part of the product package.
Designed for single-patient use, it assists professionals (physicians, researchers) and patients in
documenting and monitoring the use of their prescribed pMDI device.
Parameters of the metal canister compatible with FindAir ONE for pMDI FOMDI10:
• External shape of the canister: round
• Minimum canister diameter: 20.5 mm
• Maximum canister diameter: 23.5 mm
• Protruding above the housing by at least 7 mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260270 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260270: FindAir ONE for pMDI (FAO-MDI-V12-GRE-001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260270
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026