Cleared Traditional

K010607 - MED-RX IRRIGATION SET

K010607 is an FDA 510(k) clearance for MED-RX IRRIGATION SET, manufactured by Benlan, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LJH cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K010607 · Benlan, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
272d
Days
Class 2
Risk

K010607 is an FDA 510(k) clearance for the MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001. Classified as System, Irrigation, Urological (product code LJH), Class II - Special Controls.

Submitted by Benlan, Inc. (Oakville, CA). The FDA issued a Cleared decision on November 28, 2001 after a review of 272 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 Benlan, Inc. devices

FDA 510(k) Submission Details - K010607

510(k) Number K010607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2001
Decision Date November 28, 2001
Days to Decision 272 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 130d · This submission: 272d
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 10
Devices cleared under the same product code (LJH) and FDA review panel - the closest regulatory comparables to K010607.
Karl Storz UROMAT E.A.S.I.
K162992 · KARL STORZ Endoscopy-America, Inc. · Jul 2017
FLO ASSISTANT, MODEL 4-250-00
K001325 · Northgate Technologies, Inc. · Aug 2000
KSEA UROPUMP
K981615 · KARL STORZ Endoscopy-America, Inc. · Jul 1998
KARL STORZ MODEL 203020 20 EQUIMAT
K971982 · KARL STORZ Endoscopy-America, Inc. · Aug 1997
MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET
K970946 · Medline Industries, Inc. · Jun 1997
TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS
K960787 · Baxter Healthcare Corp · May 1996