Cleared Special

Monarch Platform (K211493) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K211493 · Auris Health, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
57d
Days
Class 2
Risk

K211493 is an FDA 510(k) clearance for the Monarch Platform. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Auris Health, Inc. (Redwood, US). The FDA issued a Cleared decision on July 9, 2021 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Auris Health, Inc. devices

Submission Details

510(k) Number K211493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2021
Decision Date July 09, 2021
Days to Decision 57 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 89d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 136
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K211493.
Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
K212048 · Intuitive Surgical, Inc. · Aug 2021
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor
K211030 · Boston Scientific Corporation · Aug 2021
Broncho Videoscope System
K210379 · Scivita Medical Technology Co., Ltd. · Jul 2021
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
K210883 · Ambu A/S · Jun 2021
Rescue Pulmonary Grasping Forceps
K202987 · Anrei Medical (Hangzhou) Co., Ltd. · Apr 2021
SPiN Vision Video Bronchoscope System
K202346 · Veran Medical Technologies, Inc. · Feb 2021