Cleared Traditional

K962850 - TUM-E-VAC

K962850 is an FDA 510(k) clearance for TUM-E-VAC, manufactured by Ethox Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KDH cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K962850 · Ethox Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
214d
Days
Class 2
Risk

K962850 is an FDA 510(k) clearance for the TUM-E-VAC. Classified as Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration (product code KDH), Class II - Special Controls.

Submitted by Ethox Corp. (Buffalo, US). The FDA issued a Cleared decision on February 21, 1997 after a review of 214 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Ethox Corp. devices

FDA 510(k) Submission Details - K962850

510(k) Number K962850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1996
Decision Date February 21, 1997
Days to Decision 214 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 131d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDH Device Classification - Class 2, Special Controls

Product Code KDH Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KDH Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration

All 10
Devices cleared under the same product code (KDH) and FDA review panel - the closest regulatory comparables to K962850.
GILTECH PLUS CONNECTING TUBE SET
K983624 · Giltech Plus, Inc. · Mar 1999
SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
K981286 · Armm, Inc. · Jun 1998
COMBIPORT FLUID LAVAGE DEVICE
K971259 · B.Braun Medical, Inc. · Oct 1997
EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT
K951533 · Ballard Medical Products · Jul 1995
FLUSHING IRRIGATION SET
K923497 · Orion Life Systems, Inc. · Mar 1994
HEMORRHOIDAL LIGATOR WITH SUCTION
K900086 · Baxter Healthcare Corp · Mar 1990