Cleared Traditional

K861181 - NORTA TEFLON COATED LATEX BALLOON CATHETERS

K861181 is an FDA 510(k) clearance for NORTA TEFLON COATED LATEX BALLOON CATHETERS, manufactured by Beiersdorf, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K861181 · Beiersdorf, Inc. · Gastroenterology & Urology device
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Apr 1986
Decision
8d
Days
Class 2
Risk

K861181 is an FDA 510(k) clearance for the NORTA TEFLON COATED LATEX BALLOON CATHETERS. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on April 8, 1986 after a review of 8 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 Beiersdorf, Inc. devices

FDA 510(k) Submission Details - K861181

510(k) Number K861181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1986
Decision Date April 08, 1986
Days to Decision 8 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 130d · This submission: 8d
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 129
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K861181.
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
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
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP
K852084 · The Kendal Co. · Sep 1985