Cleared Traditional

K050188 - EPIGUARD

K050188 is an FDA 510(k) clearance for EPIGUARD, manufactured by Episafe Medical Devices, Ltd.. The device is a Class 2 Neurology device with product code JXL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K050188 · Episafe Medical Devices, Ltd. · Neurology device
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Apr 2005
Decision
90d
Days
Class 2
Risk

K050188 is an FDA 510(k) clearance for the EPIGUARD. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by Episafe Medical Devices, Ltd. (Somerset, US). The FDA issued a Cleared decision on April 27, 2005 after a review of 90 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 Episafe Medical Devices, Ltd. devices

FDA 510(k) Submission Details - K050188

510(k) Number K050188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2005
Decision Date April 27, 2005
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
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 13
Devices cleared under the same product code (JXL) and FDA review panel - the closest regulatory comparables to K050188.
PATI (Protector Against Tongue Injury)
K221469 · Neurovice, LLC · Feb 2023
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
K201309 · Mecta Corporation · Jun 2021
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
BITE BLOCK
K954352 · United States Endoscopy Group, Inc. · Jan 1996