Cleared Abbreviated

K103349 - BACKSTOP CATHETER

K103349 is an FDA 510(k) clearance for BACKSTOP CATHETER, manufactured by Pluromed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Abbreviated 510(k) pathway after a 52-day FDA review.

K103349 · Pluromed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
52d
Days
Class 2
Risk

K103349 is an FDA 510(k) clearance for the BACKSTOP CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Pluromed, Inc. (Woburn, US). The FDA issued a Cleared decision on January 7, 2011 after a review of 52 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Pluromed, Inc. devices

FDA 510(k) Submission Details - K103349

510(k) Number K103349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2010
Decision Date January 07, 2011
Days to Decision 52 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 130d · This submission: 52d
Pathway characteristics
Standards-based clearance path.

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 130
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K103349.
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K171662 · Cook Incorporated · Feb 2018
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INTERMITTENT URETHRAL CATHETERS
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