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Monarch Platform

by Auris Health, Inc. 2 variants

510(k) K193534

Monarch Platform is a medical device (FDA Class II; FDA product code EOQ, Bronchoscope (Flexible Or Rigid)) made by Auris Health, Inc., cleared under FDA 510(k) K193534 on 15 Apr 2020, active as of 8 Nov 2026. 4 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK193534 Date15 Apr 2020ClearedStatusActive

Official records

Recalls

4 recalls · 4 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.

  • 3 recalls, same reason

    • Ongoing Z-0448-2024 FDA Class II initiated 18 Oct 2023
    • Ongoing Z-0449-2024 FDA Class II initiated 18 Oct 2023
    • Ongoing Z-0450-2024 FDA Class II initiated 18 Oct 2023

    Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.

Timeline

5 dated events

  1. Cleared FDA 510(k) K193534
  2. Recall initiated FDA recalls Z-0448-2024
  3. Recall initiated FDA recalls Z-0449-2024
  4. Recall initiated FDA recalls Z-0450-2024
  5. Recall initiated FDA recalls Z-1383-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EOQ
Device class
Class II
Regulation
21 CFR Part 874.4680
Advisory committee
Ear, Nose, Throat
FDA decision
SESE Substantially Equivalent

Related clearances

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

Cited by

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

Devices cleared under K193534

5 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 K193534
UDI-DISize and differences
Monarch Bronchoscope MBR-000211-A
Auris Health, Inc.
MBR-000211-A / MBR-000211-AB623MBR000211A0
Single use: yes
No longer on the market
Monarch Bronchoscope MBR-000211-A
Auris Health, Inc.
MRB-000211-A / MBR-000211-A10810068810865
Single use: yes
On the market
Monarch Bronchoscope MBR-000211-A
Auris Health, Inc.
MRB-000211-A / MBR-000211-AB634MBR000211A0
Single use: yes
On the market
MONARCH™ Controller MON-000706
Auris Health, Inc.
MON-000706 / MON-00070610810068810858
Single use: no
On the market
MONARCH™ Navigation Sensors MON-000705
Auris Health, Inc.
MON-000705 / MON-00070510810068810841
Single use: no
On the market

Similar devices

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

Other devices from Auris Health, Inc.

See all devices from Auris Health, Inc. →