Cleared Traditional

Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US (K243497) - FDA 510(k) Clearance

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

K243497 · Shanghai AnQing Medical Instrument Co., Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
198d
Days
Class 2
Risk

K243497 is an FDA 510(k) clearance for the Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12U.... Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Shanghai AnQing Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on May 29, 2025 after a review of 198 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 Shanghai AnQing Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K243497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2024
Decision Date May 29, 2025
Days to Decision 198 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
109d slower than avg
Panel avg: 89d · This submission: 198d
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 129
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K243497.
FUJIFILM Endoscope Model EB-710P
K244017 · Fujifilm Corporation · Jun 2025
Disposable Balloon Catheter B5-2C
K250118 · Olympus Medical Systems Corporation · Jun 2025
Disposable Biopsy Forceps (FB-211D)
K250957 · Olympus Medical Systems Corporation · May 2025
Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0
K242793 · Shenzhen Insighters Medical Technology Co., Ltd. · May 2025
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