510(k) · Cleared
ClearedThe Vest APX System (PVAPX1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corportation · BYI Percussor, Powered-Electric
Cleared on Mar 22, 2024 as substantially equivalent to K142482 (Hill-Rom Services Private Limited, 2015) after a 156-day review. Its family tree reaches back 6 generations to 1988.
- Decided
- Mar 22, 2024
- Review
- 156 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K884098 (1988). No later device cites it as a predicate yet.
- Root · 6 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 5 generations backK965192 Thairapy Vest SystemAmerican Biosystems, Inc. · 1997
- 4 generations backK993629 Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000
- 3 generations backK012928 Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001
- 2 generations backK024309 The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003
- 1 generation backK142482 The Vest Airway Clearance SystemHill-Rom Services Private Limited · 2015
- This deviceK233441 The Vest APX System (PVAPX1)Baxter Healthcare Corportation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −5 | K965192 | Thairapy Vest System | American Biosystems, Inc. | 1997 | — |
| −4 | K993629 | Abi Vest Airway Clearance System | American Biosystems, Inc. | 2000 | — |
| −3 | K012928 | Abi Vest Airway Clearance System | Advanced Respiratory | 2001 | — |
| −2 | K024309 | The Vest Airway Clearance System, Model 104 | Advanced Respiratory | 2003 | — |
| −1 | K142482 | The Vest Airway Clearance System | Hill-Rom Services Private Limited | 2015 | — |
| 0 (this device) | K233441 | The Vest APX System (PVAPX1) | Baxter Healthcare Corportation | 2024 | — |
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 |
|---|---|---|---|
| * | K142482 | The Vest Airway Clearance SystemSummary page 5…Table 2. Predicate Device(s) Device Company Predicate 510(k) Clearance Date The Vest Airway Hill-Rom Services K142482 May 7, 2015 Clearance Systems Private Limited DESCRIPTION OF THE DEVICE: The Vest APX System is a high-fr… | 2015 |
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 36 years and passes through 4 companies; a new generation was cleared every 8.5 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K142482.
How does its category compare?
All BYI devicesBYI Percussor, Powered-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 APX System is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. 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 APX System is also indicated for…
Read the full statement (108 words)
The Vest APX System is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. 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 APX 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.
The Vest APX System may be used for the pediatric population (6 months and older) to geriatric population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233441 · printed Nov 3, 2026
Cite this page
510(k) Report. “K233441: The Vest APX System (PVAPX1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K233441
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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