Cleared Traditional

K862124 - POLYMED LABORATORIES ALL SILICONE FOLEY...

K862124 is an FDA 510(k) clearance for POLYMED LABORATORIES ALL SILICONE FOLEY..., manufactured by Polymed Laboratories. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K862124 · Polymed Laboratories · Gastroenterology & Urology device
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Aug 1986
Decision
72d
Days
Class 2
Risk

K862124 is an FDA 510(k) clearance for the POLYMED LABORATORIES ALL SILICONE FOLEY CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Polymed Laboratories (Tustin, US). The FDA issued a Cleared decision on August 14, 1986 after a review of 72 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 Polymed Laboratories devices

FDA 510(k) Submission Details - K862124

510(k) Number K862124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1986
Decision Date August 14, 1986
Days to Decision 72 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
58d faster than avg
Panel avg: 130d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

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 130
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K862124.
BIO-GUARD AB COATED CATHETER
K863354 · Cook Urological, Inc. · Nov 1986
FOLEY CATHETERS
K863517 · Instrumentation Industries, Inc. · Oct 1986
MODIFIED FOLEY CATHETER
K863302 · Sheridan Catheter Corp. · Oct 1986
NORTA TEFLON COATED LATEX BALLOON CATHETERS
K861181 · Beiersdorf, Inc. · Apr 1986
VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH.
K860337 · Van-Tec, Inc. · Mar 1986
CURITY & KENGUARD SILICONE COATED FOLEY CATHETER
K860484 · The Kendal Co. · Mar 1986