Cleared Special

K091699 - AMSURE HYDROPHILIC LATEX FOLEY CATHETER

K091699 is the FDA 510(k) clearance for AMSURE HYDROPHILIC LATEX FOLEY CATHETER by Amsino International, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EZL) cleared through the Special 510(k) pathway after a 61-day FDA review.

K091699 · Amsino International, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
61d
Days
Class 2
Risk

K091699 is an FDA 510(k) clearance for the AMSURE HYDROPHILIC LATEX 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 August 10, 2009 after a review of 61 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Amsino International, Inc. devices

Submission Details

510(k) Number K091699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2009
Decision Date August 10, 2009
Days to Decision 61 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 130d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 59
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K091699.
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K091767 · Cook Urological, Inc. · Oct 2009
BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS
K070558 · C.R. Bard, Inc. · Dec 2007
BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS
K070582 · C.R. Bard, Inc. · Dec 2007
MEDLINE LATEX FOLEY CATHETER
K071423 · Medline Industries, Inc. · Jul 2007