Cleared Traditional

K023690 - CATHETER CONNECTOR

K023690 is an FDA 510(k) clearance for CATHETER CONNECTOR, manufactured by World Metals, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K023690 · World Metals, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
119d
Days
Class 2
Risk

K023690 is an FDA 510(k) clearance for the CATHETER CONNECTOR. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by World Metals, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on February 28, 2003 after a review of 119 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 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 World Metals, Inc. devices

FDA 510(k) Submission Details - K023690

510(k) Number K023690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2002
Decision Date February 28, 2003
Days to Decision 119 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
12d faster than avg
Panel avg: 131d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
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 - KNY Accessories, Catheter, G-u

All 53
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K023690.
MICROVERTER URETERAL ACCESS SHEATH
K042877 · Percutaneous Systems, Inc. · Nov 2004
SLIP UROLOGY INTRODUCER SHEATH
K040520 · Percutaneous Systems, Inc. · May 2004
HEMEDEX FIXATION DEVICE
K032127 · Hemedex Incorporated · Dec 2003
MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201
K000767 · Memcath Technologies, LLC · Jun 2000
PBN DRAINAGE CATHETER GUIDEWIRES
K991097 · Medical Device Technologies, Inc. · Apr 1999
SNAP-N-PEEL INTRODUCERS
K981611 · Circon Corp. · Jul 1998