Cleared Traditional

K113424 - LOFRIC SINGLE USE URINARY CATHETER

K113424 is an FDA 510(k) clearance for LOFRIC SINGLE USE URINARY CATHETER, manufactured by Astra Tech AB. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K113424 · Astra Tech AB · Gastroenterology & Urology device
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Apr 2012
Decision
148d
Days
Class 2
Risk

K113424 is an FDA 510(k) clearance for the LOFRIC SINGLE USE URINARY CATHETER. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Astra Tech AB (San Diego, US). The FDA issued a Cleared decision on April 17, 2012 after a review of 148 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 Astra Tech AB devices

FDA 510(k) Submission Details - K113424

510(k) Number K113424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2011
Decision Date April 17, 2012
Days to Decision 148 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
17d slower than avg
Panel avg: 131d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZD Device Classification - Class 2, Special Controls

Product Code EZD Catheter, Straight
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 - EZD Catheter, Straight

All 75
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K113424.
HYDROSIL
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K122078 · Astra Tech, Inc. · Oct 2012
COMFORTGLIDE INTERMITENT CATHETER
K112137 · C.R. Bard, Inc. · Aug 2011
CURE CATHETER
K110653 · Cure Medical, LLC · Aug 2011
MEDLINE PVC URETHRAL CATHETER
K100302 · Medline Industries, Inc. · Jul 2010