510(k) · Cleared
ClearedThairapy Vest System
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 Jun 24, 1997 as substantially equivalent to K884098 (American Biosystems, Inc., 1988) after a 182-day review. Its family tree reaches back 1 generation to 1988. 23 later devices descend from it.
- Decided
- Jun 24, 1997
- Review
- 182 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884098 (1988). 23 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- This deviceK965192 Thairapy Vest SystemAmerican Biosystems, Inc. · 1997
- Descendant · cites it directly · 19 of its ownK993629 Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000
- Descendant · 2 generations on · 18 of its ownK012928 Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001
- Descendant · 2 generations on · 13 of its ownK024309 The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003
- Descendant · 3 generations on · 5 of its ownK142482 The Vest Airway Clearance SystemHill-Rom Services Private Limited · 2015
- Descendant · 3 generations on · 4 of its ownK122111 Respironics Simplyclear DeviceRespironics, Inc. · 2012
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K993629Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000 · cites it directly19descendants
- K012928Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001 · 2 generations on18descendants
- K024309The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003 · 2 generations on13descendants
- K142482The Vest Airway Clearance SystemHill-Rom Services Private Limited · 2015 · 3 generations on5descendants
- K122111Respironics Simplyclear DeviceRespironics, Inc. · 2012 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| 0 (this device) | K965192 | Thairapy Vest System | American Biosystems, Inc. | 1997 | — |
| +1 | K993629 | Abi Vest Airway Clearance System | American Biosystems, Inc. | 2000 | — |
| +2 | K012928 | Abi Vest Airway Clearance System | Advanced Respiratory | 2001 | — |
| +2 | K024309 | The Vest Airway Clearance System, Model 104 | Advanced Respiratory | 2003 | — |
| +3 | K142482 | The Vest Airway Clearance System | Hill-Rom Services Private Limited | 2015 | — |
| +3 | K122111 | Respironics Simplyclear Device | Respironics, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 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 |
|---|---|---|---|
| * | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101Summary page 1…llip R. Rose, Quality Assurance and Regulatory Affairs Name of Device: ThAIRapy® System Classification: Powered Percussor, Class 11 Predicate Device: ThAIRapy® System, K884098 Description of Device: The ThAIRapy® System is a high-frequency chest wall oscillator designed be used in a wide variety of set… | 1988 |
What descends from it? (23)
See all 233 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?
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 intended ase of the modified ThAIRapy® Vest is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practice Guidelines for Postural Drainage Therapy.' According to AARC guidelines, the goals of airway clearance therapy are to…
Read the full statement (118 words)
The intended ase of the modified ThAIRapy® Vest is the same as the predicate device,
which is to provide airway clearance therapy when external manipulation of thorax is the
physician's choice of treatment. Indications for this form of therapy are described by the
American Association for Respiratory Care (AARC) in the Clinical Practice Guidelines for
Postural Drainage Therapy.' According to AARC guidelines, the goals of airway clearance
therapy are to improve mobilization of bronchial secretions, match ventilation and
perfusion, and normalize functional residual capacity. Specific indications for external
manipulation of the thorax include evidence or a suggestion of retained secretions, evidence
that the patient is having difficulty with secretion clearance, or presence of atelectasis
caused by mucus plugging.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965192 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965192: Thairapy Vest System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965192
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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