510(k) · Cleared
ClearedMonarch Airway Clearance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom Holdings, Inc. · BYI Percussor, Powered-Electric
Cleared on Oct 24, 2018 as substantially equivalent to K163378 (Hill-Rom Services Pte, Ltd., 2017) after a 337-day review. Its family tree reaches back 7 generations to 1988. 1 later device descends from it.
- Decided
- Oct 24, 2018
- Review
- 337 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K884098 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 6 generations backK965192 Thairapy Vest SystemAmerican Biosystems, Inc. · 1997
- 5 generations backK993629 Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000
- 4 generations backK012928 Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001
- 3 generations backK024309 The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003
- 2 generations backK142482 The Vest Airway Clearance SystemHill-Rom Services Private Limited · 2015
- 1 generation backK163378 Monarch Airway Clearance SystemHill-Rom Services Pte, Ltd. · 2017 · Recalled
- This deviceK173603 Monarch Airway Clearance SystemHill-Rom Holdings, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK201490 Electro Flo 6 Airway Clearance SystemMed Systems, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K201490Electro Flo 6 Airway Clearance SystemMed Systems, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −6 | K965192 | Thairapy Vest System | American Biosystems, Inc. | 1997 | — |
| −5 | K993629 | Abi Vest Airway Clearance System | American Biosystems, Inc. | 2000 | — |
| −4 | K012928 | Abi Vest Airway Clearance System | Advanced Respiratory | 2001 | — |
| −3 | K024309 | The Vest Airway Clearance System, Model 104 | Advanced Respiratory | 2003 | — |
| −2 | 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 |
| 0 (this device) | K173603 | Monarch Airway Clearance System | Hill-Rom Holdings, Inc. | 2018 | — |
| +1 | K201490 | Electro Flo 6 Airway Clearance System | Med Systems, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K163378 | Monarch Airway Clearance SystemSummary page 4…e/Name: BYI – electric-powered, percussor 21 CFR 868.5665 Class II Predicate Device: K163378 – Hill-Rom Monarch® Airway Clearance System Model 1000 Device Description: The Monarch® Airway C… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201490 | Electro Flo 6 Airway Clearance System | 2021 | 0 |
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 30 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K201490 (Med Systems, Inc., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BYI devicesBYI Percussor, Powered-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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/K173603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K173603: Monarch 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/K173603
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