Cleared Traditional

K842420 - NORTA SILICONIZED LATEX BALLOON CATH.

K842420 is an FDA 510(k) clearance for NORTA SILICONIZED LATEX BALLOON CATH., 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 154-day FDA review.

K842420 · Beiersdorf, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K842420

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
Combination Product No
PCCP Authorized No
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.

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 K842420.
UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER
K851857 · Sheridan Catheter Corp. · Jul 1985
DIAFLEX OCCLUSION BALLOON CATHETER
K850790 · American Edwards Laboratories · Mar 1985
URETEROSCOPY CATHETER
K850335 · Inmed Corp. · Mar 1985
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