Cleared Traditional

K830803 - URINARY DIVERSION STENT

K830803 · Van-Tec, Inc. · Gastroenterology & Urology device

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May 1983

Decision

52d

Days

Risk

K830803 is an FDA 510(k) clearance for the URINARY DIVERSION STENT. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Van-Tec, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 5, 1983 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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 - K830803

510(k) Number	K830803 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 14, 1983
Decision Date	May 05, 1983
Days to Decision	52 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

79d faster than avg

Panel avg: 131d · This submission: 52d

Pathway characteristics

Predicate-based equivalence.

LJE Device Classification - Class 0,

Product Code	LJE Catheter, Nephrostomy
Device Class	-

Regulatory Peers - LJE Catheter, Nephrostomy

All 53

Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K830803.

E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS

K841720 · E-Z-Em, Inc. · Jul 1984

NEPHROSTOMY/BILIARY DRAINAGE BAG

K834476 · Vertex Medical Corp. · Feb 1984

PERCUTANEOUS NEPHROSTOMY CATHETER

K833008 · Medical Engineering Corp. · Oct 1983

SURGITEK PERCUTANEOUS NEPHROSTOMY CATH

K830226 · Medical Engineering Corp. · Feb 1983

HEYER-SCHUTE UNIVERSAL URETERAL STENT

K823418 · American Hospital Supply Corp. · Dec 1982

SURGITEK PERCUTANEOUS NEPHROST. STENT

K821776 · Medical Engineering Corp. · Aug 1982

FDA 510(k) Resources - Gastroenterology & Urology

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

Manufacturer of K830803

Van-Tec, Inc.

Mchenry, IL · US

Regulatory profile

52 submissions 52 cleared

100% clearance rate · Active in Gastroenterology & Urology

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: May 5, 1983. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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510k Database

510(k) clearances indexed 175,972

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