Cleared Traditional

K250732 - Disposable Endoscopy Valve Set

K250732 is an FDA 510(k) clearance for Disposable Endoscopy Valve Set, manufactured by Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code ODC cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K250732 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
101d
Days
Class 2
Risk

K250732 is an FDA 510(k) clearance for the Disposable Endoscopy Valve Set. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Yangzhou Fartley Medical Instrument Technology Co., Ltd. (Yangzhou, CN). The FDA issued a Cleared decision on June 20, 2025 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Yangzhou Fartley Medical Instrument Technology Co., Ltd. devices

FDA 510(k) Submission Details - K250732

510(k) Number K250732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2025
Decision Date June 20, 2025
Days to Decision 101 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
29d faster than avg
Panel avg: 130d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODC Device Classification - Class 2, Special Controls

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
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 - ODC Endoscope Channel Accessory

All 50
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K250732.
Biopsy Port Adapter
K250145 · Endosound, Inc. · Oct 2025
Orca Air/Water and Suction Valves
K252910 · Boston Scientific · Oct 2025
Suction Valve (MAJ-1443)
K250949 · Olympus Medical Systems Corporation · Jul 2025
Luer-Split MAJ-2092
K241842 · Olympus Medical Systems Corporation · Mar 2025
Defendo Fujifilm 700 Single Use Cleaning Adapter
K250140 · Steris Corparation · Feb 2025
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
K243075 · STERIS Corporation · Nov 2024