Cleared Traditional

K820868 - URETERAL CATHETER CONNECTOR

K820868 is an FDA 510(k) clearance for URETERAL CATHETER CONNECTOR, manufactured by Van-Tec, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K820868 · Van-Tec, Inc. · Gastroenterology & Urology device
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Apr 1982
Decision
28d
Days
Class 2
Risk

K820868 is an FDA 510(k) clearance for the URETERAL CATHETER CONNECTOR. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Van-Tec, Inc. (Walker, US). The FDA issued a Cleared decision on April 26, 1982 after a review of 28 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 Van-Tec, Inc. devices

FDA 510(k) Submission Details - K820868

510(k) Number K820868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1982
Decision Date April 26, 1982
Days to Decision 28 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
103d faster than avg
Panel avg: 131d · This submission: 28d
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 154
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K820868.
FOLEY INSERTION TRAYS W/OVERWRAY
K820987 · Inmed Corp. · May 1982
CURITY ECONOMY I CYSTOSCOPY
K820838 · The Kendal Co. · May 1982
URETERAL CATHETER CONNECTING TUBE
K820866 · Van-Tec, Inc. · Apr 1982
RETRIEVAL FORCEPS
K820239 · American Endoscopy, Inc. · Mar 1982
AM. PH. STERILE SINGLE-USE URETHRAL CATH
K820419 · American Pharmaseal Div. Ahsc · Mar 1982
VANCE-JACOBELLIS MICROHEMATURIA CATHETER
K812995 · Vance Products, Inc. · Mar 1982