Cleared Traditional

NORTA SILICONIZED LATEX BALLOON CATH. (K842420) - FDA 510(k) Clearance

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

K842420 · Beiersdorf, Inc. · Gastroenterology & Urology device
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Nov 1984
Decision
154d
Days
Class 2
Risk

K842420 is an FDA 510(k) clearance for the NORTA SILICONIZED LATEX BALLOON CATH.. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Beiersdorf, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 21, 1984 after a review of 154 days - an extended review 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: 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 Beiersdorf, Inc. devices

Submission Details

510(k) Number K842420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1984
Decision Date November 21, 1984
Days to Decision 154 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
24d slower than avg
Panel avg: 130d · This submission: 154d
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 39
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K842420.
PHARMASEAL DISPOSABLE ABDOMINAL TROCAR
K904734 · Baxter Healthcare Corp · Nov 1990
BARD CONFORMACATH FOLEY CATHETER
K900229 · C.R. Bard, Inc. · Apr 1990
CATHETER STRAP
K881781 · Baxter Healthcare Corp · Aug 1988
UROLOGICAL KIT W/STERILE, WATER-FILL
K841485 · Medline Industries, Inc. · May 1984
TEMPERATURE SENSING FOLEY CATHETER
K834438 · C.R. Bard, Inc. · Feb 1984
IMPROVED SILICATH SILICONE ELASTOMER
K832165 · Travenol Laboratories, S.A. · Aug 1983