Cleared Traditional

K842228 - AIMED FOLEY CATHETER VARIOUS SIZES

K842228 is the FDA 510(k) clearance for AIMED FOLEY CATHETER VARIOUS SIZES by Tech-Cons Ltd., Intl.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K842228 · Tech-Cons Ltd., Intl. · Gastroenterology & Urology device
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Sep 1984
Decision
97d
Days
Class 2
Risk

K842228 is an FDA 510(k) clearance for the AIMED FOLEY CATHETER VARIOUS SIZES. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Tech-Cons Ltd., Intl. (Mchenry, US). The FDA issued a Cleared decision on September 10, 1984 after a review of 97 days - within the typical 510(k) review window.

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 Tech-Cons Ltd., Intl. devices

Submission Details

510(k) Number K842228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1984
Decision Date September 10, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 130d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
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 - KOD Catheter, Urological

All 121
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K842228.
DIAFLEX OCCLUSION BALLOON CATHETER
K850790 · American Edwards Laboratories · Mar 1985
URETEROSCOPY CATHETER
K850335 · Inmed Corp. · Mar 1985
NORTA SILICONIZED LATEX BALLOON CATH.
K842420 · Beiersdorf, Inc. · Nov 1984
URETHRAL CATHETERIZATION TRAY
K842866 · Inmed Corp. · Sep 1984
PERCUFIX CATHETER CUFF
K842890 · Medi-Tech, Inc. · Sep 1984
VAN-TEC OCCLUSION BALLOON CATHETER
K841941 · Van-Tec, Inc. · Aug 1984