Cleared Traditional

K013345 - INCARE INTERMITTENT CATHETER

K013345 is an FDA 510(k) clearance for INCARE INTERMITTENT CATHETER, manufactured by Hollister, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013345 · Hollister, Inc. · Gastroenterology & Urology device
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Jan 2002
Decision
90d
Days
Class 2
Risk

K013345 is an FDA 510(k) clearance for the INCARE INTERMITTENT CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on January 7, 2002 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 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K013345

510(k) Number K013345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2001
Decision Date January 07, 2002
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

Product Code KOD Catheter, 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 - KOD Catheter, Urological

All 129
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K013345.
INTERMITTENT URETHRAL CATHETERS
K033023 · Rusch Intl. · Dec 2003
URETERAL ACCESS SHEATH SET (UASS)
K022135 · Boston Scientific Corp · Sep 2002
INCARE ADVANCE
K013483 · Hollister, Inc. · Jan 2002
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · Boston Scientific Corp · Jul 2001
FLOCATH
K000070 · Rusch Intl. · Feb 2000
IMAGER TORQUE CATHETER
K965229 · Boston Scientific Corp · Mar 1997