Cleared Abbreviated

OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 (K990509) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K990509 · Implemed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
89d
Days
Class 2
Risk

K990509 is an FDA 510(k) clearance for the OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Implemed, Inc. (Watertown, US). The FDA issued a Cleared decision on May 18, 1999 after a review of 89 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 Implemed, Inc. devices

Submission Details

510(k) Number K990509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1999
Decision Date May 18, 1999
Days to Decision 89 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
41d faster than avg
Panel avg: 130d · This submission: 89d
Pathway characteristics
Standards-based clearance path.

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 127
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K990509.
Rusch SoftSimplastic Foley Catheters
K252537 · Teleflex Medical Sdn. Bhd. · Jan 2026
Silicone Urethral Catheter (Silicone Urethral Catheter)
K243011 · Guangdong Ecan Medical Co., Ltd. · Jun 2025
InnoCare Specialty Foley Catheter
K241424 · Innocare Urologics, LLC · Sep 2024
Rüsch Latex Gold Foley Catheter
K232469 · Teleflexmedical, Inc. · Aug 2024
TraumaGuard Intra-abdominal Pressure Sensing System
K240057 · Sentinel Medical Technologies, LLC · Apr 2024
Folysil Silicone Catheter
K233411 · Coloplast Corp. · Apr 2024