510(k) · Cleared
ClearedBreatheSuite MDI V1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Breathesuite, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Sep 17, 2021 as substantially equivalent to K142516 (Reciprocal Labs Corporation, 2015) after a 330-day review. Its family tree reaches back 6 generations to 1982.
- Decided
- Sep 17, 2021
- Review
- 330 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. No later device cites it as a predicate yet.
- 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 deviceK203155 BreatheSuite MDI V1Breathesuite, Inc. · 2021
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) | K203155 | BreatheSuite MDI V1 | Breathesuite, Inc. | 2021 | — |
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 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.
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 39 years and passes through 5 companies; a new generation was cleared every 6.3 years on median.
- None of the 9 ancestors has a recall.
- 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. 2021, 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 BreatheSuite MDI Device is an electronic device intended for single-patient use of patients 5 years of age and older. It assists patients in recording and monitoring the actuations and technique of prescribed metered dose inhaler (MDI) usage. The BreatheSuite System is composed of the disposable, battery powered, portable BreatheSuite MDI Device and a mobile application. The BreatheSuite MDI Device is an accessory designed to work with an MDI by…
Read the full statement (291 words)
The BreatheSuite MDI Device is an electronic device intended for single-patient use of patients 5 years of age and older.
It assists patients in recording and monitoring the actuations and technique of prescribed metered dose inhaler (MDI)
usage. The BreatheSuite System is composed of the disposable, battery powered, portable BreatheSuite MDI Device and a
mobile application.
The BreatheSuite MDI Device is an accessory designed to work with an MDI by attaching to the top of the canister of the
inhaler. The BreatheSuite MDI Device does not interfere with regular MDI usage and can be removed and reattached with
ease. The BreatheSuite MDI Device does not actuate the inhaler but rather gathers information based on manual MDI
usage.
The BreatheSuite MDI Device measures the parameters of MDI use and records them for review by the patient. The
BreatheSuite application records, stores, and transmits usage events from the BreatheSuite MDI Device to a remote
storage system. Furthermore, BreatheSuite MDI reminds the patient of important steps of MDI use through visual
feedback in the BreatheSuite application.
The output of the BreatheSuite System is not intended to diagnose or replace a diagnosis provided by a licensed physician.
The BreatheSuite 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. The BreatheSuite MDI Device is not intended to replace a physician's
advice or inhaler labels; patients are expected to always follow their doctor's advice and inhaler labels.
The BreatheSuite System can be used both indoors and outdoors as well as in home and work settings.
The BreatheSuite System may also be used in clinical trials where researchers need to know information about use of a
MDI Medication(s) by a participant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203155: BreatheSuite MDI V1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203155
Report an extraction error
Are you the manufacturer?
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