Monarch Platform (MON-000008) Robotic Bronchoscopy System

Regulatory status

as of registry sync 8 Nov 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK243219	Date23 Jan 2025Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K243219

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-1383-2026 FDA Class II initiated 21 Jan 2026
Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.

Timeline

2 dated events

23 Jan 2025 Cleared FDA 510(k) K243219
21 Jan 2026 Recall initiated FDA recalls Z-1383-2026

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K243219
FDA product code: EOQ

Device class: Class II
Regulation: 21 CFR Part 874.4680
Advisory committee: Ear, Nose, Throat
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Monarch Platform K211493 9 Jul 2021 FDA record · FDA summary

Cited by

MONARCH™ Platform (MON-000008) K260382 25 Jul 2026 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K243219

12 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K243219
		UDI-DI	Size and differences
Extended Patient Introducer Mount MON-000713 Auris Health, Inc.	MON-000713 / MON-000713	10810068811275	—	On the market
Monarch Endoscopy Controller MON-000712 Auris Health, Inc.	MON-000712	10810068810971	—	On the market
Monarch Platform, Bronchoscopy 4.1, Refurbished MON-000008-RFB Auris Health, Inc.	MON-000008-RFB	10810068811169	—	On the market
Monarch Platform, Bronchoscopy MON-000008 Auris Health, Inc.	MON-000008	10810068810988	—	On the market
Monarch™ Cart Software v4.1.0 Version 4.1.0 Auris Health, Inc.	Version 4.1.0	10810068810599	—	On the market
Monarch™ Cart Software v4.1.1 Version 4.1.1 Auris Health, Inc.	Version 4.1.1	10810068811503	—	On the market
Monarch™ Laptop P16 Software v4.1.0 Version 4.1.0 Auris Health, Inc.	Version 4.1.0	10810068810612	—	On the market
Monarch™ Laptop P16 Software v4.1.1 Version 4.1.1 Auris Health, Inc.	Version 4.1.1	10810068811527	—	On the market
Monarch™ Laptop P17 Software v4.1.0 Version 4.1.0 Auris Health, Inc.	Version 4.1.0	10810068810605	—	On the market
Monarch™ Laptop P17 Software v4.1.1 Version 4.1.1 Auris Health, Inc.	Version 4.1.1	10810068811510	—	On the market
Monarch™ Tower Software v4.1.0 Version 4.1.0 Auris Health, Inc.	Version 4.1.0	10810068810582	—	On the market
Monarch™ Tower Software v4.1.1 Version 4.1.1 Auris Health, Inc.	Version 4.1.1	10810068811497	—	On the market

Similar devices

Other devices filed under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)).

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