# K193534: Monarch Platform

- Pathway: 510(k) (Traditional)
- Applicant: Auris Health, Inc.
- Decided: Apr 15, 2020 after 117 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955065 (1996). 7 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173760: Monarch Endoscopy Platform (Monarch Platform), Auris Surgical Robotics, Inc. (2018) Summary page 4.

## Most influential descendants
- K211493: Monarch Platform (2021), 2 descendants of its own
- K243219: MONARCH™ Platform (MON-000008) (2025), 1 descendant of its own
- K203614: Monarch Bronchoscope (2021), 1 descendant of its own
- K260382: MONARCH™ Platform (MON-000008) (2026), 0 descendants of its own
- K231473: Monarch Bronchoscope (2023), 0 descendants of its own

## Recalls of this device
- Jan 21, 2026 · Class II · Z-1383-2026: 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
- Oct 18, 2023 · Class II · Z-0448-2024: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
- Oct 18, 2023 · Class II · Z-0450-2024: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
- Oct 18, 2023 · Class II · Z-0449-2024: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.

## Indications for use
The Monarch Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K193534
Methodology: https://510kreport.com/methodology