Cleared Traditional

DUTAU-NOVATECH® (K242324) - FDA 510(k) Clearance

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

K242324 · Novatech SA · Ear, Nose, Throat device
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Feb 2025
Decision
184d
Days
Class 2
Risk

K242324 is an FDA 510(k) clearance for the DUTAU-NOVATECH®. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Novatech SA (La Ciotat Cedex, FR). The FDA issued a Cleared decision on February 6, 2025 after a review of 184 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 Novatech SA devices

Submission Details

510(k) Number K242324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2024
Decision Date February 06, 2025
Days to Decision 184 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
95d slower than avg
Panel avg: 89d · This submission: 184d
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 K242324.
LumiRex Bronchoscope
K243541 · Contra Healthcare Solutions, LLC · Apr 2025
Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P)
K250210 · Scivita Medical Technology Co., Ltd. · Mar 2025
Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8
K242010 · Shenzhen Sanping Image Technology Co., Ltd. · Mar 2025
MONARCH™ Platform (MON-000008)
K243219 · Auris Health, Inc. · Jan 2025
Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12
K242416 · Hunan Vathin Medical Instrument Co., Ltd. · Jan 2025
Video Bronchoscope System
K241612 · Hunan Vathin Medical Instrument Co., Ltd. · Oct 2024