Cleared Traditional

K921946 - TUM-E-VAC BITE BLOCK

K921946 is an FDA 510(k) clearance for TUM-E-VAC BITE BLOCK, manufactured by Ethox Corp.. The device is a Class 2 Neurology device with product code JXL cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K921946 · Ethox Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
226d
Days
Class 2
Risk

K921946 is an FDA 510(k) clearance for the TUM-E-VAC BITE BLOCK. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by Ethox Corp. (Buffalo, US). The FDA issued a Cleared decision on December 9, 1992 after a review of 226 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5070 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K921946

510(k) Number K921946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1992
Decision Date December 09, 1992
Days to Decision 226 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 149d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXL Device Classification - Class 2, Special Controls

Product Code JXL Block, Bite
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5070
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 Neurology devices follow this clearance model.

Regulatory Peers - JXL Block, Bite

All 25
Devices cleared under the same product code (JXL) and FDA review panel - the closest regulatory comparables to K921946.
PREMIER PROMAX BITE GUARD
K941856 · Premier Dental Products Co. · Apr 1995
THE DAVIS DISPOSABLE PROTECTIVE SPLINT
K924333 · Ora-Gard, Inc. · Apr 1993
BITE BLOCK
K924304 · United States Endoscopy Group, Inc. · Apr 1993
MOUTHPIECE BREATHING
K901563 · Scott All-Sports, Inc. · Jun 1990
JAW BLOCKER
K896745 · Plastic Engineered Products Co. · Dec 1989
BITE BLOCK #59430
K890567 · Medi-Source, Inc. · Feb 1989
K921946 · TUM-E-VAC BITE BLOCK
Download PDF Ethox Corp.