Cleared Traditional

Monarch Platform (K193534) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193534 · Auris Health, Inc. · Ear, Nose, Throat device
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Apr 2020
Decision
117d
Days
Class 2
Risk

K193534 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 April 15, 2020 after a review of 117 days - within the typical 510(k) review window.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Auris Health, Inc. devices

Submission Details

510(k) Number K193534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2019
Decision Date April 15, 2020
Days to Decision 117 days
Submission Type Traditional
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
28d slower than avg
Panel avg: 89d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K193534.
PENTAX Medical Video Bronchoscope EB-J10 Series
K200678 · Pentax of America, Inc. · Jul 2020
Ion Endoluminal System
K201146 · Intuitive Surgical, Inc. · Jun 2020
Single Use Biopsy Forceps FB-456D
K200397 · Olympus Medical Systems Corp. · Apr 2020
Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
K192164 · Olympus Medical Systems Corp. · Mar 2020
Vathin Video Bronchoscope System
K191828 · Hunan Vathin Medical Instrument Co., Ltd. · Feb 2020
GlideScope BFlex 3.8 Single-Use Bronchoscope
K193488 · Verathon Medical (Canada) Ulc · Jan 2020