510(k) · Cleared
Recalled · Class II · 2017Monarch Airway Clearance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom Services Pte, Ltd. · BYI Percussor, Powered-Electric
Cleared on Mar 17, 2017 as substantially equivalent to K142482 (Hill-Rom Services Private Limited, 2015) after a 106-day review. Its family tree reaches back 6 generations to 1988. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 17, 2017
- Review
- 106 days
- Class
- Class II
- Product code
- BYI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K884098 (1988). 2 later devices descend from it, 1 citing it directly.
- 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 deviceK163378 Monarch Airway Clearance SystemHill-Rom Services Pte, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK173603 Monarch Airway Clearance SystemHill-Rom Holdings, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK201490 Electro Flo 6 Airway Clearance SystemMed Systems, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView 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) | K163378 | Monarch Airway Clearance System | Hill-Rom Services Pte, Ltd. | 2017 | — |
| +1 | K173603 | Monarch Airway Clearance System | Hill-Rom Holdings, Inc. | 2018 | — |
| +2 | K201490 | Electro Flo 6 Airway Clearance System | Med Systems, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K142482 | The Vest Airway Clearance SystemSummary page 4…me: BYI – electric-powered, percussor 21 CFR 868.5665 Class II Predicate Device: K142482 – Hill-Rom – Vest® Model 105 Reference Device: K122480 – IBC – AffloVest Device Description: The Monarch™ Airway… | 2015 |
| † | K122480 | International Biophysics Corporation Afflovest | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173603 | Monarch Airway Clearance System | 2018 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 15, 2017 | Class II | Z-0192-2018 | Other | Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subject to an EMI if they come into direct contact with the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K173603 (Hill-Rom Holdings, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 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. 2017, 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 Monarch™ product is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician’s choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.
The Monarch™ Airway Clearance System is intended to be used in the Home Care environment by patients, 15 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163378: Monarch 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/K163378
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