Cleared Traditional

K254111 - Irrigation/Urology Sets

K254111 is an FDA 510(k) clearance for Irrigation/Urology Sets, manufactured by B.Braun Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LJH cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K254111 · B.Braun Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
265d
Days
Class 2
Risk

K254111 is an FDA 510(k) clearance for the Irrigation/Urology Sets. Classified as System, Irrigation, Urological (product code LJH), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Center Valley, US). The FDA issued a Cleared decision on September 10, 2026 after a review of 265 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K254111

510(k) Number K254111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2025
Decision Date September 10, 2026
Days to Decision 265 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
134d slower than avg
Panel avg: 131d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJH Device Classification - Class 2, Special Controls

Product Code LJH System, Irrigation, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - LJH System, Irrigation, Urological

All 21
Devices cleared under the same product code (LJH) and FDA review panel - the closest regulatory comparables to K254111.
Karl Storz UROMAT E.A.S.I.
K162992 · KARL STORZ Endoscopy-America, Inc. · Jul 2017
AMSURE BLADDER IRRIGATION SET
K070873 · Amsino Intl., Inc. · Dec 2007
MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM
K071832 · Medical Scientific, Inc. · Sep 2007
SPYGLASS IRRIGATION SYSTEM
K063700 · Medical Scientific, Inc. · Feb 2007
NEXUS IRRIGATION TUBING SET
K062551 · Nexus Medical, LLC · Dec 2006
URO PRO
K042457 · W.O.M. World of Medicine AG · Oct 2004