# Monarch Platform

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/monarch-platform-eoq-k193534>
- Manufacturer: [Auris Health, Inc.](https://devicerts.com/manufacturers/auris-health-inc) (United States)
- Device class: Class II (US FDA)
- FDA product code: EOQ

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K193534 · decision 2020-04-15 · decision SESE · status: Active

## Recalls

- Z-1383-2026 · Class II · ongoing · initiated 2026-01-21: 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.
- Z-0448-2024 · Class II · ongoing · initiated 2023-10-18: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
- Z-0449-2024 · Class II · ongoing · initiated 2023-10-18: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
- Z-0450-2024 · Class II · ongoing · initiated 2023-10-18: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.

## Identifiers

- 510(k) Number: K193534 [FDA 510(k)]
- FDA product code: EOQ [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 874.4680 [FDA 510(k)]
- Advisory committee: Ear, Nose, Throat [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Monarch Platform, Auris Health, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/monarch-platform-eoq-k193534 (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-11-08
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/monarch-platform-eoq-k193534.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/monarch-platform-eoq-k193534
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.