Cleared Traditional

K954352 - BITE BLOCK

K954352 is an FDA 510(k) clearance for BITE BLOCK, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Neurology device with product code JXL cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K954352 · United States Endoscopy Group, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
129d
Days
Class 2
Risk

K954352 is an FDA 510(k) clearance for the BITE BLOCK. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on January 25, 1996 after a review of 129 days - within the typical 510(k) review window.

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 United States Endoscopy Group, Inc. devices

FDA 510(k) Submission Details - K954352

510(k) Number K954352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1995
Decision Date January 25, 1996
Days to Decision 129 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
19d faster than avg
Panel avg: 148d · This submission: 129d
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 12
Devices cleared under the same product code (JXL) and FDA review panel - the closest regulatory comparables to K954352.
SurgeoBite
K172978 · Surgovations, LLC · Dec 2017
VENTIL-A ORAL PROTECTOR
K992269 · Somatics, Inc. · Oct 1999
UNIVERSAL BITE BLOCK
K960663 · B&B Medical Technologies, Inc. · May 1996
PREMIER PROMAX BITE GUARD
K941856 · Premier Dental Products Co. · Apr 1995
BITE BLOCK
K924304 · United States Endoscopy Group, Inc. · Apr 1993
TUM-E-VAC BITE BLOCK
K921946 · Ethox Corp. · Dec 1992