Monarch Platform (MON-000008)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243219 FDA 510(k)
- FDA Product Code
- EOQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4680 FDA 510(k)
- Regulation Number
- 874.4680 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Monarch Platform (MON-000008) is a robotic, electromechanical, flexible bronchoscopy system designed for bronchoscopic visualization and access to patient airways. It functions as a Class 2 Ear, Nose, and Throat device, enabling diagnostic and therapeutic procedures within the respiratory tract.
This device is supplied as a reusable medical system and is regulated under FDA 510(k) clearance (K243219) via the Traditional pathway. Cleared for use in clinical settings, it adheres to Ear, Nose, and Throat product code EOQ standards and was reviewed by the Ear, Nose, Throat Advisory Committee.
Frequently asked questions
What types of medical procedures can the Monarch Platform assist with in the respiratory tract?
The Monarch Platform is designed for bronchoscopic procedures, enabling both diagnostic and therapeutic interventions within the airways. This includes visualization and access for tasks like biopsies, lesion removal, or other interventions where precise navigation of the bronchial tree is required.
Is the Monarch Platform reusable, and if so, what does that mean for maintenance and cleaning?
Yes, the Monarch Platform is supplied as a reusable medical system. This means it is intended for multiple uses after proper cleaning, sterilization, and maintenance as outlined in the manufacturer’s instructions to ensure safety and functionality between procedures.
How is the Monarch Platform regulated by the FDA, and what does that mean for clinical adoption?
The Monarch Platform received FDA clearance via the Traditional 510(k) pathway (K243219) and is classified as a Class 2 Ear, Nose, and Throat device under product code EOQ. This clearance indicates it has been deemed substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed and used in clinical settings in the U.S.
What does the advisory committee review process entail for this device, and how does it impact its development?
The Monarch Platform was reviewed by the Ear, Nose, and Throat (EN) Advisory Committee as part of the FDA’s 510(k) submission process. This committee provides expert input on whether the device meets safety and effectiveness standards for its intended use, ensuring it aligns with established clinical practices before clearance.
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: Auris Health, Inc. FDA 510 (k) Products - Latest 2026, MONARCH™ Platform (MON-000008) (K243219) — FDA 510(k) | Innolitics, K243219 FDA 510 (k) - MONARCH Platform (MON-000008), MONARCH Platform… — K260382 · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243219 | Class II | Active |
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Manufacturer
- Manufacturer
- Auris Health, Inc
- FDA Applicant
- Auris Health, Inc.
Sources (1)
- FDA 510(k) K243219 24 fields · synced Sep 19, 2026