Cleared Traditional

K150518 - Airway with Bite Block and Tongue Depre...

K150518 is the FDA 510(k) clearance for Airway with Bite Block and Tongue Depre... by Dupaco, Inc.. It is a Class 2 Neurology device (product code JXL) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K150518 · Dupaco, Inc. · Neurology device
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Jun 2015
Decision
119d
Days
Class 2
Risk

K150518 is an FDA 510(k) clearance for the Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and.... Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by Dupaco, Inc. (Oceanside, US). The FDA issued a Cleared decision on June 29, 2015 after a review of 119 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 Dupaco, Inc. devices

Submission Details

510(k) Number K150518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2015
Decision Date June 29, 2015
Days to Decision 119 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
29d faster than avg
Panel avg: 148d · This submission: 119d
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

Devices cleared under the same product code (JXL) and FDA review panel - the closest regulatory comparables to K150518.
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
BITE BLOCK
K954352 · United States Endoscopy Group, Inc. · Jan 1996
BITE BLOCK
K924304 · United States Endoscopy Group, Inc. · Apr 1993
JACKSON BITE BLOCKS
K822018 · Kelleher Corp. · Aug 1982