Cleared Traditional

K250118 - Disposable Balloon Catheter B5-2C

K250118 is the FDA 510(k) clearance for Disposable Balloon Catheter B5-2C by Olympus Medical Systems Corporation. It is a Class 2 Anesthesiology device (product code EOQ) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K250118 · Olympus Medical Systems Corporation · Anesthesiology device
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Jun 2025
Decision
139d
Days
Class 2
Risk

K250118 is an FDA 510(k) clearance for the Disposable Balloon Catheter B5-2C. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Hachioji-Shi, JP). The FDA issued a Cleared decision on June 4, 2025 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 874.4680 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K250118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2025
Decision Date June 04, 2025
Days to Decision 139 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 140d · This submission: 139d
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 178
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K250118.
Vathin® Video Bronchoscope System
K250232 · Hunan Vathin Medical Instrument Co., Ltd. · Jul 2025
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190)
K250862 · Olympus Medical Systems Corp. · Jun 2025
FUJIFILM Endoscope Model EB-710P
K244017 · Fujifilm Corporation · Jun 2025
Disposable Biopsy Forceps (FB-211D)
K250957 · Olympus Medical Systems Corporation · May 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. · May 2025
Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0
K242793 · Shenzhen Insighters Medical Technology Co., Ltd. · May 2025