Cleared Traditional

K260382 - MONARCH Platform (MON-000008)

K260382 is an FDA 510(k) clearance for MONARCH Platform (MON-000008), manufactured by Auris Health, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K260382 · Auris Health, Inc. · Ear, Nose, Throat device
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Jul 2026
Decision
170d
Days
Class 2
Risk

K260382 is an FDA 510(k) clearance for the MONARCH™ Platform (MON-000008). Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Auris Health, Inc. (Santa Clara, US). The FDA issued a Cleared decision on July 25, 2026 after a review of 170 days - an extended review 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. 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

FDA 510(k) Submission Details - K260382

510(k) Number K260382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2026
Decision Date July 25, 2026
Days to Decision 170 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 89d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOQ Device Classification - Class 2, Special Controls

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 188
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K260382.
FUJIFILM Endoscope Model EB-840S
K253137 · Fujifilm Corporation · Jun 2026
SmartClip Delivery Catheter (ADR-1715)
K260565 · Elucent Medical · May 2026
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190)
K252341 · Olympus Medical Systems Corp. · Apr 2026
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
K260420 · MacroLux Medical Technology Co., Ltd. · Apr 2026
FUJIFILM Ultrasonic Endoscope EB-710US
K250863 · Fujifilm Corporation · Dec 2025
KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)
K251731 · Karl Storz SE & CO. KG · Dec 2025