Cleared Traditional

K896729 - NELATON-, FEMALE - OR TIEMANN CATHETER

K896729 is an FDA 510(k) clearance for NELATON-, manufactured by Unoplast A/S. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K896729

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
209d slower than avg
Panel avg: 131d · This submission: 340d
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 160
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K896729.
NAUDE URETHRAL STENT
K912851 · Cook Urological, Inc. · Jan 1992
KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER
K911242 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1991
PHARMASEAL DISPOSABLE ABDOMINAL TROCAR
K904734 · Baxter Healthcare Corp · Nov 1990
BARD CONFORMACATH FOLEY CATHETER
K900229 · C.R. Bard, Inc. · Apr 1990
DISPOSABLE URODYNAMIC CATHETER SET
K896784 · Life-Tech Intl., Inc. · Feb 1990
CONVEEN INTERMITTENT CATHETERS
K895548 · Coloplast A/S · Feb 1990