Cleared Traditional

K820866 - URETERAL CATHETER CONNECTING TUBE

K820866 is the FDA 510(k) clearance for URETERAL CATHETER CONNECTING TUBE by Van-Tec, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K820866 · Van-Tec, Inc. · Gastroenterology & Urology device

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Apr 1982

Decision

28d

Days

Class 2

Risk

K820866 is an FDA 510(k) clearance for the URETERAL CATHETER CONNECTING TUBE. 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

Submission Details

510(k) Number	K820866 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

102d faster than avg

Panel avg: 130d · This submission: 28d

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 115

Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K820866.

BARDEX ALL SILICONE PEDIATRIC CATHETER

K821745 · C.R. Bard, Inc. · Jun 1982

BN-74 COATED BARDEX ALL SILICONE CATH

K821272 · C.R. Bard, Inc. · Jun 1982

CURITY ECONOMY I CYSTOSCOPY

K820838 · The Kendal Co. · May 1982

URETERAL CATHETER CONNECTOR

K820868 · Van-Tec, Inc. · Apr 1982

AM. PH. STERILE SINGLE-USE URETHRAL CATH

K820419 · American Pharmaseal Div. Ahsc · Mar 1982

ROBINSON CATHETERS NON-STERILE

K812887 · Abco Dealers, Inc. · Nov 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K820866

Van-Tec, Inc.

Walker, MI · US

Regulatory profile

52 submissions 52 cleared

100% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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