Cleared Traditional

K250409 - Disposable Balloon Catheter (B5-2Q) (FDA 510(k) Clearance)

Also includes:
Disposable Balloon Catheter (B7-2Q) Disposable Balloon Catheter (B7-2LA)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250409 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
250d
Days
Class 2
Risk

K250409 is an FDA 510(k) clearance for the Disposable Balloon Catheter (B5-2Q). Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Hachioji-Shi, JP). The FDA issued a Cleared decision on October 21, 2025 after a review of 250 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K250409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2025
Decision Date October 21, 2025
Days to Decision 250 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 130d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGE Stents, Drains And Dilators For The Biliary Ducts

All 473
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K250409.
Dilation Balloon Catheter
K253832 · Mirco-Tech (Nanjing) Co., Ltd. · Apr 2026
Endoflux™ Biliary & Pancreatic Stent Sets
K251658 · Medi-Globe GmbH · Apr 2026
BARE Wireguided Balloon Dilation Catheter (1235)
K253987 · GIE Medical · Mar 2026
Single use stone retrieval balloons
K253132 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 2026
Niti-S Biliary Stent
K251123 · Taewoong Medical Co., Ltd. · Dec 2025
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
K251019 · Bioteque Corporation · Dec 2025