Cleared Traditional

K031409 - URINARY CATHETERS

K031409 is an FDA 510(k) clearance for URINARY CATHETERS, manufactured by Promedic, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K031409 · Promedic, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
43d
Days
Class 2
Risk

K031409 is an FDA 510(k) clearance for the URINARY CATHETERS. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Promedic, Inc. (Mccordsville, US). The FDA issued a Cleared decision on June 17, 2003 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Promedic, Inc. devices

FDA 510(k) Submission Details - K031409

510(k) Number K031409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2003
Decision Date June 17, 2003
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
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 47
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K031409.
SPEEDICATH COMPACT
K072808 · Coloplast Corp. · Nov 2007
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
SPEEDICATH
K023254 · Coloplast Corp. · Jan 2003
RUSCH FLONEIL
K020714 · Rusch Intl. · Jul 2002
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
K012374 · Astra Tech, Inc. · Aug 2001