510(k) · Cleared
ClearedThe Incourage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respiratory Technologies, Incorporated · BYI Percussor, Powered-Electric
Cleared on Jun 17, 2005 as substantially equivalent to K024309 (Advanced Respiratory, 2003) after a 21-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Jun 17, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K884098 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 4 generations backK965192 Thairapy Vest SystemAmerican Biosystems, Inc. · 1997
- 3 generations backK993629 Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000
- 2 generations backK012928 Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001
- 1 generation backK024309 The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003
- This deviceK051383 The Incourage SystemRespiratory Technologies, Incorporated · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −4 | K965192 | Thairapy Vest System | American Biosystems, Inc. | 1997 | — |
| −3 | K993629 | Abi Vest Airway Clearance System | American Biosystems, Inc. | 2000 | — |
| −2 | K012928 | Abi Vest Airway Clearance System | Advanced Respiratory | 2001 | — |
| −1 | K024309 | The Vest Airway Clearance System, Model 104 | Advanced Respiratory | 2003 | — |
| 0 (this device) | K051383 | The Incourage System | Respiratory Technologies, Incorporated | 2005 | — |
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 BYI? 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 BYI device
- #1 K252849 AffloVest® Mobile Airway Clearance Therapyscore 12.5 · 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 |
|---|---|---|---|
| * | K024309 | The Vest Airway Clearance System, Model 104Summary page 2…m :-1 Comparison of Technological Characteristics: The inCourage TM System is equivalent to The VestTm Airway Clearance System. Model 104 (K024309) in that it has the same indications for use, the same target population, the jacket and vest materials are both made of similar… | 2003 |
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 17 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K024309.
How does its category compare?
All BYI devicesBYI Percussor, Powered-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BYI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BYI
157in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BYI
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BYI
38in 2025
MAUDE reports naming product code BYI, 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 | 1 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 1 | — | 0 | 17 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 3 | 225 | 0 | 6 |
| 2014 | 0 | — | 1 | 10 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 1 | 4 |
| 2018 | 1 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 3 | 157 | 0 | 19 |
| 2025 | 1 | — | 0 | 38 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The inCourage TM System is indicated when external manipulation
of the chest is the physician's treatment of choice for increasing
the clearance of mucus in patients with pulmonary disorders.
The system promotes airway clearance and improves bronchial
drainage utilizing High Frequency Chest Wall Oscillation
(HFCWO).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051383 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051383: The Incourage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051383
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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