Cleared Traditional

K921946 - TUM-E-VAC BITE BLOCK

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

K921946 · Ethox Corp. · Neurology device
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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.

View all Ethox Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 148d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (JXL) and FDA review panel - the closest regulatory comparables to K921946.
BITE BLOCK
K954352 · United States Endoscopy Group, Inc. · Jan 1996
PREMIER PROMAX BITE GUARD
K941856 · Premier Dental Products Co. · Apr 1995
BITE BLOCK
K924304 · United States Endoscopy Group, Inc. · Apr 1993
GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
K861893 · Hi Chem, Inc. · Jun 1986
JACKSON BITE BLOCKS
K822018 · Kelleher Corp. · Aug 1982