Cleared Traditional

K992269 - VENTIL-A ORAL PROTECTOR

K992269 is an FDA 510(k) clearance for VENTIL-A ORAL PROTECTOR, manufactured by Somatics, Inc.. The device is a Class 2 Neurology device with product code JXL cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K992269 · Somatics, Inc. · Neurology device
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Oct 1999
Decision
111d
Days
Class 2
Risk

K992269 is an FDA 510(k) clearance for the VENTIL-A ORAL PROTECTOR. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by Somatics, Inc. (Lake Bluff, US). The FDA issued a Cleared decision on October 25, 1999 after a review of 111 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 Somatics, Inc. devices

FDA 510(k) Submission Details - K992269

510(k) Number K992269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1999
Decision Date October 25, 1999
Days to Decision 111 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
37d faster than avg
Panel avg: 148d · This submission: 111d
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 14
Devices cleared under the same product code (JXL) and FDA review panel - the closest regulatory comparables to K992269.
SurgeoBite
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EPIGUARD
K050188 · Episafe Medical Devices, Ltd. · Apr 2005
UNIVERSAL BITE BLOCK
K960663 · B&B Medical Technologies, Inc. · May 1996
BITE BLOCK
K954352 · United States Endoscopy Group, Inc. · Jan 1996
PREMIER PROMAX BITE GUARD
K941856 · Premier Dental Products Co. · Apr 1995