Cleared Traditional

K030120 - AMSURE FOLEY CATHETER

K030120 is an FDA 510(k) clearance for AMSURE FOLEY CATHETER, manufactured by Amsino International, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K030120 · Amsino International, Inc. · Gastroenterology & Urology device
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Oct 2003
Decision
289d
Days
Class 2
Risk

K030120 is an FDA 510(k) clearance for the AMSURE FOLEY CATHETER. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Amsino International, Inc. (Ontario, US). The FDA issued a Cleared decision on October 29, 2003 after a review of 289 days - an extended review 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: 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 Amsino International, Inc. devices

FDA 510(k) Submission Details - K030120

510(k) Number K030120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2003
Decision Date October 29, 2003
Days to Decision 289 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 131d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZL Device Classification - Class 2, Special Controls

Product Code EZL Catheter, Retention Type, Balloon
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 - EZL Catheter, Retention Type, Balloon

All 100
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K030120.
DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
K042709 · Tyco Healthcare · Jan 2005
OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016
K041983 · Opticon Medical · Nov 2004
BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS
K040504 · C.R. Bard, Inc. · May 2004
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
K002612 · C.R. Bard, Inc. · Sep 2002
DRAINAGE CATHETER OR FOLEY CATHETER
K010006 · Applied Medical Resources Corp. · Jul 2001
MENTOR SELF-CATH PLUS
K003784 · Mentor Corp. · Mar 2001