510(k) · Cleared
ClearedOchsner Connected Inhaler Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ochsner Clinic Foundation · CAF Nebulizer (Direct Patient Interface)
Cleared on Aug 30, 2023 as substantially equivalent to K142516 (Reciprocal Labs Corporation, 2015) after a 299-day review. Its family tree reaches back 6 generations to 1982. 1 later device descends from it.
- Decided
- Aug 30, 2023
- Review
- 299 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K823423 (1982). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK823423 Nebulizer Chronolog & InterpreterAdvanced Technology Products, Inc. · 1982
- 5 generations backK970344 Mdilog, Model MDC-511Medtrak Technologies, Inc. · 1997
- 4 generations backK091803 Smarttrack SystemNexus6, Ltd. · 2009
- 3 generations backK121609 Asthmapolis SystemReciprocal Labs Corporation · 2012
- 2 generations backK140638 Propeller System - Model 2Reciprocal Labs Corporation · 2014
- 1 generation backK142516 Propeller SystemReciprocal Labs Corporation · 2015
- This deviceK223367 Ochsner Connected Inhaler SensorOchsner Clinic Foundation · 2023
- Descendant · cites it directly · 0 of its ownK260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K823423 | Nebulizer Chronolog & Interpreter | Advanced Technology Products, Inc. | 1982 | — |
| −5 | K970344 | Mdilog, Model MDC-511 | Medtrak Technologies, Inc. | 1997 | — |
| −4 | K091803 | Smarttrack System | Nexus6, Ltd. | 2009 | — |
| −3 | K121609 | Asthmapolis System | Reciprocal Labs Corporation | 2012 | — |
| −2 | K140638 | Propeller System - Model 2 | Reciprocal Labs Corporation | 2014 | — |
| −1 | K142516 | Propeller System | Reciprocal Labs Corporation | 2015 | — |
| 0 (this device) | K223367 | Ochsner Connected Inhaler Sensor | Ochsner Clinic Foundation | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K142516 | Propeller SystemSummary page 5…n: 21 CFR §868.5630 Product Code: CAF Device Description: Electronic MDI Accessory Predicate Device: Propeller System Model 2 OTC K142516 Intended Use: The Ochsner Connected Inhaler Sensor System includes the Ochsner Conn… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | 2026 | 0 |
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 41 years and passes through 5 companies; a new generation was cleared every 8.3 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K260270 (FindAir Sp. z o.o., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K142516.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Ochsner Connected Inhaler Sensor System includes the Ochsner Connected Inhaler Sensor. The Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring actuations of prescribed MDI usage. The Ochsner Connected Inhaler Sensor Mobile Application records, stores, and transmits usage events from the Sensors to a remote storage system. With the Mobile Application, the user can review…
Read the full statement (276 words)
The Ochsner Connected Inhaler Sensor System includes the Ochsner Connected Inhaler Sensor. The Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring actuations of prescribed MDI usage.
The Ochsner Connected Inhaler Sensor Mobile Application records, stores, and transmits usage events from the Sensors to a remote storage system. With the Mobile Application, the user can review information collected from the Sensors 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, physicians, and health care providers.
When used with a prescribed MDI, 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 MDI technique.
When used under the care of a physician with a prescribed MDI, the System can assist in the management of respiratory health symptoms and exacerbations by providing feedback through reminders, notifications, and self-management education.
The System is intended to be used in populations from Child (>2 years) to adult.
The System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.
The System may also be used in clinical trials where researchers need to know information about the use of MDI medications by a participant.
The output of the System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The System is not intended for use as an MDI or inhaled medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI or inhaled medication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223367 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223367: Ochsner Connected Inhaler Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223367
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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