Cleared Traditional

VANCE UROSTOMY APPLIANCE (K803048) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K803048 · Vance Products, Inc. · Gastroenterology & Urology device
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Dec 1980
Decision
21d
Days
Class 1
Risk

K803048 is an FDA 510(k) clearance for the VANCE UROSTOMY APPLIANCE. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Vance Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - 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 Vance Products, Inc. devices

Submission Details

510(k) Number K803048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1980
Decision Date December 22, 1980
Days to Decision 21 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
109d faster than avg
Panel avg: 130d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXB Collector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EXB Collector, Ostomy

All 22
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K803048.
WOUND DRAINAGE MANAGEMENT SYSTEMS
K813080 · Howmedica Corp. · Nov 1981
FORMULATION CHANGE IN UNITED SKIN BARR
K810726 · Howmedica Corp. · Jun 1981
DRAINING-WOUND MGMT. SYSTEM
K810812 · Johnson & Johnson Professionals, Inc. · Apr 1981
ADHESIVE PERISTOMAL COVERING W/WO CONN.
K803082 · Johnson & Johnson Professionals, Inc. · Dec 1980
CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON
K802677 · Johnson & Johnson Professionals, Inc. · Nov 1980
SUPER BANISH DEODORANT
K801471 · Howmedica Corp. · Jul 1980