Monarch Airway Clearance System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163378 FDA 510(k)
- FDA Product Code
- BYI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5665 FDA 510(k)
- Regulation Number
- 868.5665 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Monarch Airway Clearance System is a powered-electric percussor that uses Pulmonary Oscillating Discs (PODs) to generate oscillations and targeted kinetic energy to the lungs, helping to thin mucus and increase airflow. It provides airway clearance therapy, mobilizing secretions from the airways. The device is classified as a Class 2 device with the product code BYI. The Monarch Airway Clearance System is substantially equivalent to other devices and has a regulation number of 868.5665.
The Monarch Airway Clearance System is supplied with a model number, such as Model 1000, and is intended for use in anesthesiology. It is a mobile High Frequency Chest Wall Oscillation (HFCWO) therapy device. The system has received FDA 510K authorization and has a K number of K163378. The device is used to help patients with airway clearance, and patients with certain conditions may require specialized therapy regimens in conjunction with the Monarch Airway Clearance System.
Frequently asked questions
What is the Monarch Airway Clearance System used for?
The Monarch Airway Clearance System is used to help patients with airway clearance, mobilizing secretions from the airways, and is intended for use in anesthesiology.
Is the Monarch Airway Clearance System a single-use or reusable device?
The device description does not specify whether the Monarch Airway Clearance System is single-use or reusable, but it is a mobile High Frequency Chest Wall Oscillation therapy device.
What is the regulatory status of the Monarch Airway Clearance System?
The Monarch Airway Clearance System has received FDA 510K authorization with a K number of K163378 and is classified as a Class 2 device.
What model numbers are available for the Monarch Airway Clearance System?
The device is supplied with a model number, such as Model 1000, but other models may be available.
What type of therapy does the Monarch Airway Clearance System provide?
The Monarch Airway Clearance System provides airway clearance therapy and High Frequency Chest Wall Oscillation therapy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF 202182-EN-r6_Monarch-Patient_Brochure_LR.pdf - Hill-Rom, PDF Instructions for Use - Monarch Airway Clearance System, Model 1000, Monarch Airway Clearance System (Home Care) | Baxter Pro US - Hill-Rom
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163378 | Class II | Active |
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Manufacturer
- Manufacturer
- Hill-Rom Services Pte. Ltd.
- FDA Applicant
- Hill-Rom Services Pte, Ltd.
Sources (1)
- FDA 510(k) K163378 24 fields · synced Sep 26, 2026