Cleared Abbreviated

K040094 - PIGGYBACK IRRIGATING SYSTEM

K040094 is an FDA 510(k) clearance for PIGGYBACK IRRIGATING SYSTEM, manufactured by Kosin Technologies, LLC. The device is a Class 2 Gastroenterology & Urology device with product code LJH cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K040094 · Kosin Technologies, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
90d
Days
Class 2
Risk

K040094 is an FDA 510(k) clearance for the PIGGYBACK IRRIGATING SYSTEM. Classified as System, Irrigation, Urological (product code LJH), Class II - Special Controls.

Submitted by Kosin Technologies, LLC (Valparaiso, US). The FDA issued a Cleared decision on April 15, 2004 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Kosin Technologies, LLC devices

FDA 510(k) Submission Details - K040094

510(k) Number K040094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2004
Decision Date April 15, 2004
Days to Decision 90 days
Submission Type Abbreviated
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
41d faster than avg
Panel avg: 131d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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 22
Devices cleared under the same product code (LJH) and FDA review panel - the closest regulatory comparables to K040094.
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
IRRIGATION SETS
K023808 · International Medsurg Connection · Mar 2003
MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
K010607 · Benlan, Inc. · Nov 2001
CONTINUOUS FLOW Y-TUBING
K010122 · G.U.-Tek · Jun 2001