Cleared Traditional

K896729 - NELATON-

K896729 is the FDA 510(k) clearance for NELATON- by Unoplast A/S. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K896729 · Unoplast A/S · Gastroenterology & Urology device
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Nov 1990
Decision
340d
Days
Class 2
Risk

K896729 is an FDA 510(k) clearance for the NELATON-, FEMALE - OR TIEMANN CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Unoplast A/S (Denmark, DK). The FDA issued a Cleared decision on November 5, 1990 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Unoplast A/S devices

Submission Details

510(k) Number K896729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1989
Decision Date November 05, 1990
Days to Decision 340 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
210d slower than avg
Panel avg: 130d · This submission: 340d
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 69
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K896729.
RADIFOCUS GUIDE WIRE M
K923607 · Terumo Medical Corp. · Oct 1992
NAUDE URETHRAL STENT
K912851 · Cook Urological, Inc. · Jan 1992
PHARMASEAL DISPOSABLE ABDOMINAL TROCAR
K904734 · Baxter Healthcare Corp · Nov 1990
BARD CONFORMACATH FOLEY CATHETER
K900229 · C.R. Bard, Inc. · Apr 1990
CONVEEN INTERMITTENT CATHETERS
K895548 · Coloplast A/S · Feb 1990
CATHETERS, MALE, FEMALE
K892691 · Zinnanti Surgical Instruments, Inc. · Jun 1989