Cleared Traditional

VANCE-JACOBELLIS MICROHEMATURIA CATHETER (K812995) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K812995 · Vance Products, Inc. · Gastroenterology & Urology device
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Mar 1982
Decision
126d
Days
Class 2
Risk

K812995 is an FDA 510(k) clearance for the VANCE-JACOBELLIS MICROHEMATURIA CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Vance Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1982 after a review of 126 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Vance Products, Inc. devices

Submission Details

510(k) Number K812995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1981
Decision Date March 01, 1982
Days to Decision 126 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
4d faster than avg
Panel avg: 130d · This submission: 126d
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 38
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K812995.
DYNACOR URETHRAL CATHETER TRAY
K821970 · Medline Industries, Inc. · Jul 1982
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
PRE-FILLED SYRINGE & CYSTOFLO URINARY BG
K811924 · Travenol Laboratories, S.A. · Nov 1981
ARGYLE ROB-NELS
K810216 · Sherwood Medical Co. · Feb 1981
ARGYLE HEMATURIA BALLOON CATHETER
K802875 · Sherwood Medical Co. · Dec 1980