Cleared Traditional

ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 (K014002) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K014002 · Fortune Medical Instrument Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
90d
Days
Class 2
Risk

K014002 is an FDA 510(k) clearance for the ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890. Classified as Catheter, Suprapubic (and Accessories) (product code KOB), Class II - Special Controls.

Submitted by Fortune Medical Instrument Corp. (Taipei Hsien, TW). The FDA issued a Cleared decision on March 4, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5090 - 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 Fortune Medical Instrument Corp. devices

Submission Details

510(k) Number K014002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2001
Decision Date March 04, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOB Catheter, Suprapubic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
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 - KOB Catheter, Suprapubic (and Accessories)

All 31
Devices cleared under the same product code (KOB) and FDA review panel - the closest regulatory comparables to K014002.
AMT Low-Profile Suprapubic Catheter & Drainage Set
K240514 · Applied Medical Technology, Inc. · Nov 2024
Cook Cystostomy Catheter Set
K181097 · Cook Incorporated · Jan 2019
One-Step Suprapubic Introducer
K182709 · Cook Incorporated · Dec 2018
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
K182066 · Cook Incorporated · Oct 2018