510(k) · Cleared
ClearedAbi Vest Airway Clearance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Respiratory · BYI Percussor, Powered-Electric
Cleared on Oct 9, 2001 as substantially equivalent to K993629 (American Biosystems, Inc., 2000) after a 39-day review. Its family tree reaches back 3 generations to 1988. 18 later devices descend from it.
- Decided
- Oct 9, 2001
- Review
- 39 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K884098 (1988). 18 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 2 generations backK965192 Thairapy Vest SystemAmerican Biosystems, Inc. · 1997
- 1 generation backK993629 Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000
- This deviceK012928 Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001
- Descendant · cites it directly · 13 of its ownK024309 The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003
- Descendant · 2 generations on · 5 of its ownK142482 The Vest Airway Clearance SystemHill-Rom Services Private Limited · 2015
- Descendant · 2 generations on · 4 of its ownK122111 Respironics Simplyclear DeviceRespironics, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK063645 Frequencer, Model 1001Dymedso, Inc. · 2007
- Descendant · 3 generations on · 2 of its ownK163378 Monarch Airway Clearance SystemHill-Rom Services Pte, Ltd. · 2017 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K024309The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003 · cites it directly13descendants
- K142482The Vest Airway Clearance SystemHill-Rom Services Private Limited · 2015 · 2 generations on5descendants
- K122111Respironics Simplyclear DeviceRespironics, Inc. · 2012 · 2 generations on4descendants
- K063645Frequencer, Model 1001Dymedso, Inc. · 2007 · cites it directly3descendants
- K163378Monarch Airway Clearance SystemHill-Rom Services Pte, Ltd. · 2017 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −2 | K965192 | Thairapy Vest System | American Biosystems, Inc. | 1997 | — |
| −1 | K993629 | Abi Vest Airway Clearance System | American Biosystems, Inc. | 2000 | — |
| 0 (this device) | K012928 | Abi Vest Airway Clearance System | Advanced Respiratory | 2001 | — |
| +1 | K024309 | The Vest Airway Clearance System, Model 104 | Advanced Respiratory | 2003 | — |
| +2 | K142482 | The Vest Airway Clearance System | Hill-Rom Services Private Limited | 2015 | — |
| +2 | K122111 | Respironics Simplyclear Device | Respironics, Inc. | 2012 | — |
| +1 | K063645 | Frequencer, Model 1001 | Dymedso, Inc. | 2007 | — |
| +3 | K163378 | Monarch Airway Clearance System | Hill-Rom Services Pte, Ltd. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K993629 | Abi Vest Airway Clearance SystemSummary page 1…n Name of Device: Modified Vest™ Airway Clearance System Classification: Powered Percussor, Class II Predicate Device: ABI Vest™ Airway Clearance System, 510(K) number: K993629 Description of Device: The Advanced Respiratory modified Vest™ Airway Clearance System is a high-frequency chest wall oscillato… | 2000 |
What descends from it? (18)
See all 182 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 13 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K024309 (Advanced Respiratory, 2003) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K993629.
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 use of the Advanced Respiratory modified Vest™ Airway Clearance System is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of the 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 Practices Guidelines for Postural Drainage Therapy' (1991). According to AARC…
Read the full statement (136 words)
The intended use of the Advanced Respiratory modified Vest™ Airway Clearance System is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of the 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 Practices Guidelines for Postural Drainage Therapy' (1991). 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. The Advanced Respiratory modified Vest™ Airway Clearance System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
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/K012928 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012928: Abi Vest Airway Clearance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012928
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026