Cleared Traditional

K051059 - AMSURE 100% SILICONE FOLEY CATHETER

K051059 is an FDA 510(k) clearance for AMSURE 100% SILICONE 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 63-day FDA review.

K051059 · Amsino International, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
63d
Days
Class 2
Risk

K051059 is an FDA 510(k) clearance for the AMSURE 100% SILICONE FOLEY CATHETER. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on June 28, 2005 after a review of 63 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 Amsino International, Inc. devices

FDA 510(k) Submission Details - K051059

510(k) Number K051059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2005
Decision Date June 28, 2005
Days to Decision 63 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
68d faster than avg
Panel avg: 131d · This submission: 63d
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 K051059.
ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
K063442 · Degania Silicone , Ltd. · Mar 2007
BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR
K070508 · C.R. Bard, Inc. · Mar 2007
MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.
K052168 · Medline Industries, Inc. · Feb 2006
BEAMCATH
K042110 · Beampoint AB · Feb 2005
DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
K042709 · Tyco Healthcare · Jan 2005
OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016
K041983 · Opticon Medical · Nov 2004