510(k) · Cleared
ClearedThairapy (TM) Bronchial Drainage System, Model 101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Biosystems, Inc. · BYI Percussor, Powered-Electric
Cleared on Dec 16, 1988 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 30 later devices descend from it.
- Decided
- Dec 16, 1988
- Review
- 79 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 3 citing it directly.
- This deviceK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- Descendant · cites it directly · 23 of its ownK965192 Thairapy Vest SystemAmerican Biosystems, Inc. · 1997
- Descendant · 2 generations on · 19 of its ownK993629 Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000
- Descendant · 3 generations on · 18 of its ownK012928 Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001
- Descendant · 3 generations on · 13 of its ownK024309 The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003
- Descendant · cites it directly · 11 of its ownK982889 Medpulse Respiratory Vest System, Model 1000Electromed, Inc. · 1999
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K965192Thairapy Vest SystemAmerican Biosystems, Inc. · 1997 · cites it directly23descendants
- K993629Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000 · 2 generations on19descendants
- K012928Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001 · 3 generations on18descendants
- K024309The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003 · 3 generations on13descendants
- K982889Medpulse Respiratory Vest System, Model 1000Electromed, Inc. · 1999 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| +1 | K965192 | Thairapy Vest System | American Biosystems, Inc. | 1997 | — |
| +2 | K993629 | Abi Vest Airway Clearance System | American Biosystems, Inc. | 2000 | — |
| +3 | K012928 | Abi Vest Airway Clearance System | Advanced Respiratory | 2001 | — |
| +3 | K024309 | The Vest Airway Clearance System, Model 104 | Advanced Respiratory | 2003 | — |
| +1 | K982889 | Medpulse Respiratory Vest System, Model 1000 | Electromed, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (30)
See all 303 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?
- Of its descendants, K965192 (American Biosystems, Inc., 1997) has gone furthest, with 23 descendants of its own.
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 | — |
https://510kreport.com/device/K884098 · printed Nov 5, 2026
Cite this page
510(k) Report. “K884098: Thairapy (TM) Bronchial Drainage System, Model 101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K884098
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026