EOQ · Class II · 21 CFR 874.4680

FDA Product Code EOQ: Bronchoscope (flexible Or Rigid)

FDA product code EOQ covers flexible and rigid bronchoscopes and their accessories.

These endoscopic instruments allow clinicians to directly visualize the airways — from the larynx to the segmental bronchi — for diagnostic and therapeutic purposes. They are used in the evaluation of lung lesions, foreign body removal, airway management, and bronchial lavage.

EOQ devices are Class II medical devices, regulated under 21 CFR 874.4680 and reviewed by the FDA Ear, Nose & Throat panel.

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Olympus Medical Systems Corp. and Ambu A/S.

244
Total
244
Cleared
125d
Avg days
1976
Since
Stable submission activity - 29 submissions in the last 2 years
Review times increasing: avg 154d recently vs 121d historically

FDA 510(k) Cleared Bronchoscope (flexible Or Rigid) Devices (Product Code EOQ)

244 devices
1–24 of 244
Cleared Sep 23, 2026
Single-use Flexible Bronchoscope
K261637
Hunan Vathin Medical Instrument Co., Ltd.
Ear, Nose, Throat · 128d
Cleared Sep 16, 2026
Ambu® aScope™ 5 Broncho 2.7/1.2
K260309
Ambu A/S
Ear, Nose, Throat · 229d
Cleared Sep 02, 2026
3.8mm Slim ProVu Video Bronchoscope (090-02-0038U)
K254026
Flexicare Medical Limited.
Ear, Nose, Throat · 260d
Cleared Jul 25, 2026
MONARCH™ Platform (MON-000008)
K260382
Auris Health, Inc.
Ear, Nose, Throat · 170d
Cleared Jul 10, 2026
LungFlow Airway Catheter
K254037
Free Flow Medical, Inc.
Anesthesiology · 206d
Cleared Jun 16, 2026
FUJIFILM Endoscope Model EB-840S
K253137
Fujifilm Corporation
Ear, Nose, Throat · 264d
Cleared May 14, 2026
SmartClip Delivery Catheter (ADR-1715)
K260565
Elucent Medical
Anesthesiology · 84d
Cleared Apr 23, 2026
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190)
K252341
Olympus Medical Systems Corp.
Ear, Nose, Throat · 269d
Cleared Apr 08, 2026
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
K260420
MacroLux Medical Technology Co., Ltd.
Ear, Nose, Throat · 58d
Cleared Dec 12, 2025
FUJIFILM Ultrasonic Endoscope EB-710US
K250863
Fujifilm Corporation
Ear, Nose, Throat · 266d
Cleared Dec 05, 2025
KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)
K251731
Karl Storz SE & CO. KG
Ear, Nose, Throat · 182d
Cleared Sep 23, 2025
Himaging Bronchscope System
K251894
Himaging Technology (Shanghai) Co., Ltd.
Ear, Nose, Throat · 95d
Cleared Sep 23, 2025
Ion Endoluminal System (IF1000)
K252045
Intuitive Surgical, Inc.
Ear, Nose, Throat · 85d
Cleared Sep 05, 2025
Ion Endoluminal System (IF1000)
K252528
Intuitive Surgical, Inc.
Ear, Nose, Throat · 25d
Cleared Aug 27, 2025
Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)
K251752
Shanghai AnQing Medical Instrument Co., Ltd.
Ear, Nose, Throat · 79d
Cleared Aug 11, 2025
UE BRONCHO Single-Use Bronchoscopes (EBS-380C)
K251823
Zhejiang UE Medical Corp.
Ear, Nose, Throat · 59d
Cleared Jul 25, 2025
Vathin® Video Bronchoscope System
K250232
Hunan Vathin Medical Instrument Co., Ltd.
Ear, Nose, Throat · 179d
Cleared Jun 23, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190)
K250862
Olympus Medical Systems Corp.
Ear, Nose, Throat · 94d
Cleared Jun 13, 2025
FUJIFILM Endoscope Model EB-710P
K244017
Fujifilm Corporation
Ear, Nose, Throat · 168d
Cleared Jun 04, 2025
Disposable Balloon Catheter B5-2C
K250118
Olympus Medical Systems Corporation
Anesthesiology · 139d
Cleared May 30, 2025
Disposable Biopsy Forceps (FB-211D)
K250957
Olympus Medical Systems Corporation
Anesthesiology · 60d
Cleared May 29, 2025
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
Shanghai AnQing Medical Instrument Co., Ltd.
Ear, Nose, Throat · 198d
Cleared May 28, 2025
Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0
K242793
Shenzhen Insighters Medical Technology Co., Ltd.
Ear, Nose, Throat · 254d
Cleared Apr 30, 2025
LumiRex Bronchoscope
K243541
Contra Healthcare Solutions, LLC
Ear, Nose, Throat · 166d

About Product Code EOQ - Regulatory Context

510(k) Submission Activity

244 total 510(k) submissions under product code EOQ since 1976, with 244 receiving FDA clearance (average review time: 125 days).

Submission volume has remained relatively stable over the observed period, with 29 submissions in the last 24 months.

FDA 510(k) Review Time - EOQ Product Code

Recent submissions under EOQ have taken an average of 154 days to reach a decision - up from 121 days historically. Manufacturers should account for longer review timelines in current project planning.

EOQ devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →