Cleared Traditional

INCARE ADVANCE (K013483) - FDA 510(k) Clearance

Also marketed or referenced as:
INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013483 · Hollister, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
87d
Days
Class 2
Risk

K013483 is an FDA 510(k) clearance for the INCARE ADVANCE. 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 14, 2002 after a review of 87 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 Hollister, Inc. devices

Submission Details

510(k) Number K013483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2001
Decision Date January 14, 2002
Days to Decision 87 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
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 39
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K013483.
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
K102527 · Boston Scientific Corporation · Nov 2010
BARD TIGERTAIL URETERAL CATHETER
K033719 · C.R. Bard, Inc. · Feb 2004
URETERAL ACCESS SHEATH SET (UASS)
K022135 · Boston Scientific Corp · Sep 2002
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · Boston Scientific Corp · Jul 2001
IMAGER TORQUE CATHETER
K965229 · Boston Scientific Corp · Mar 1997
BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY
K922527 · C.R. Bard, Inc. · Apr 1994