510(k) · Cleared
ClearedThe Vest Airway Clearance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom Services Private Limited · BYI Percussor, Powered-Electric
Cleared on May 7, 2015 as substantially equivalent to K024309 (Advanced Respiratory, 2003) after a 245-day review. Its family tree reaches back 5 generations to 1988. 5 later devices descend from it.
- Decided
- May 7, 2015
- Review
- 245 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K884098 (1988). 5 later devices descend from it, 3 citing it directly.
- 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 deviceK142482 The Vest Airway Clearance SystemHill-Rom Services Private Limited · 2015
- Descendant · cites it directly · 2 of its ownK163378 Monarch Airway Clearance SystemHill-Rom Services Pte, Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK173603 Monarch Airway Clearance SystemHill-Rom Holdings, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK242063 LibAirty Airway Clearance SystemSynchrony Medical, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK233441 The Vest APX System (PVAPX1)Baxter Healthcare Corportation · 2024
- Descendant · 3 generations on · 0 of its ownK201490 Electro Flo 6 Airway Clearance SystemMed Systems, Inc. · 2021
Most influential descendants
Showing 5 of 5 · See all- K163378Monarch Airway Clearance SystemHill-Rom Services Pte, Ltd. · 2017 · cites it directly2descendants
- K173603Monarch Airway Clearance SystemHill-Rom Holdings, Inc. · 2018 · 2 generations on1descendant
- K242063LibAirty Airway Clearance SystemSynchrony Medical, Ltd. · 2024 · cites it directly0descendants
- K233441The Vest APX System (PVAPX1)Baxter Healthcare Corportation · 2024 · cites it directly0descendants
- K201490Electro Flo 6 Airway Clearance SystemMed Systems, Inc. · 2021 · 3 generations on0descendants
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) | K142482 | The Vest Airway Clearance System | Hill-Rom Services Private Limited | 2015 | — |
| +1 | K163378 | Monarch Airway Clearance System | Hill-Rom Services Pte, Ltd. | 2017 | 1 |
| +2 | K173603 | Monarch Airway Clearance System | Hill-Rom Holdings, Inc. | 2018 | — |
| +1 | K242063 | LibAirty Airway Clearance System | Synchrony Medical, Ltd. | 2024 | — |
| +1 | K233441 | The Vest APX System (PVAPX1) | Baxter Healthcare Corportation | 2024 | — |
| +3 | K201490 | Electro Flo 6 Airway Clearance System | Med Systems, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K024309 | The Vest Airway Clearance System, Model 104Summary page 4…BYI – Powered Percussor 21 CFR 868.5665 Class 2 Predicate Devices: K024309 – The Vest® Airway Clearance System Device Description: The Vest® Airway Clearance System consists of an inflatable garment atta… | 2003 |
What descends from it? (5)
3 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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K163378 (Hill-Rom Services Pte, Ltd., 2017) has gone furthest, with 2 descendants of its own.
- 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. 2015, this device’s year, is highlighted.
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 Vest® Airway Clearance Systems is intended to provide airway clearance therapy when external manipulation of the thorax is the physician’s choice or treatment. Indications for this form of therapy are described by the American Association of Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy. According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a…
Read the full statement (121 words)
The Vest® Airway Clearance Systems is intended to provide airway clearance therapy when external manipulation of the thorax is the physician’s choice or treatment. Indications for this form of therapy are described by the American Association of Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy. According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Vest® Airway Clearance System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for the purposes of collecting mucus for diagnostic evaluation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142482: The Vest Airway Clearance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142482
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