Cleared Traditional

K023254 - SPEEDICATH

K023254 is an FDA 510(k) clearance for SPEEDICATH, manufactured by Coloplast Corp.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K023254 · Coloplast Corp. · Gastroenterology & Urology device
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Jan 2003
Decision
119d
Days
Class 2
Risk

K023254 is an FDA 510(k) clearance for the SPEEDICATH. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Coloplast Corp. (North Mankato, US). The FDA issued a Cleared decision on January 27, 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 Coloplast Corp. devices

FDA 510(k) Submission Details - K023254

510(k) Number K023254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2002
Decision Date January 27, 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.

GBM Device Classification - Class 2, Special Controls

Product Code GBM Catheter, Urethral
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 - GBM Catheter, Urethral

All 60
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K023254.
ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER
K050874 · Astra Tech, Inc. · May 2005
LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
K043241 · Astra Tech, Inc. · Dec 2004
URINARY CATHETERS
K031409 · Promedic, Inc. · Jun 2003
RUSCH FLONEIL
K020714 · Rusch Intl. · Jul 2002
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
K012374 · Astra Tech, Inc. · Aug 2001
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
K993651 · Sc Hennig Enterprises Europe Srl · Dec 1999