Cleared Traditional

K261637 - Single-use Flexible Bronchoscope

K261637 is an FDA 510(k) clearance for Single-use Flexible Bronchoscope, manufactured by Hunan Vathin Medical Instrument Co., Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K261637 · Hunan Vathin Medical Instrument Co., Ltd. · Ear, Nose, Throat device
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Sep 2026
Decision
128d
Days
Class 2
Risk

K261637 is an FDA 510(k) clearance for the Single-use Flexible Bronchoscope. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Hunan Vathin Medical Instrument Co., Ltd. (Xiangtan, CN). The FDA issued a Cleared decision on September 23, 2026 after a review of 128 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 Hunan Vathin Medical Instrument Co., Ltd. devices

FDA 510(k) Submission Details - K261637

510(k) Number K261637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2026
Decision Date September 23, 2026
Days to Decision 128 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
38d slower than avg
Panel avg: 90d · This submission: 128d
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 221
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K261637.
Ambu® aScope™ 5 Broncho 2.7/1.2
K260309 · Ambu A/S · Sep 2026
3.8mm Slim ProVu Video Bronchoscope (090-02-0038U)
K254026 · Flexicare Medical Limited. · Sep 2026
MONARCH™ Platform (MON-000008)
K260382 · Auris Health, Inc. · Jul 2026
LungFlow Airway Catheter
K254037 · Free Flow Medical, Inc. · Jul 2026
FUJIFILM Endoscope Model EB-840S
K253137 · Fujifilm Corporation · Jun 2026
SmartClip Delivery Catheter (ADR-1715)
K260565 · Elucent Medical · May 2026