Cleared Traditional

K864181 - SOMATICS MOUTH GUARD (BITE BLOCK)

K864181 is an FDA 510(k) clearance for SOMATICS MOUTH GUARD (BITE BLOCK), 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 7-day FDA review.

K864181 · Somatics, Inc. · Neurology device
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Nov 1986
Decision
7d
Days
Class 2
Risk

K864181 is an FDA 510(k) clearance for the SOMATICS MOUTH GUARD (BITE BLOCK). 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 November 3, 1986 after a review of 7 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Somatics, Inc. devices

FDA 510(k) Submission Details - K864181

510(k) Number K864181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1986
Decision Date November 03, 1986
Days to Decision 7 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d faster than avg
Panel avg: 148d · This submission: 7d
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 15
Devices cleared under the same product code (JXL) and FDA review panel - the closest regulatory comparables to K864181.
BITE BLOCK
K924304 · United States Endoscopy Group, Inc. · Apr 1993
TUM-E-VAC BITE BLOCK
K921946 · Ethox Corp. · Dec 1992
OBERTO MOUTH PROP
K864962 · Medovations, Inc. · Feb 1987
GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
K861893 · Hi Chem, Inc. · Jun 1986
DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR
K830090 · Hudson Oxygen Therapy Sales Co. · Feb 1983
JACKSON BITE BLOCKS
K822018 · Kelleher Corp. · Aug 1982