Cleared Traditional

K150518 - Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm

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

K150518 · Dupaco, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K150518

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Regulatory Specialist, Inc.
GREG HOLLAND

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JXL Block, Bite

All 14
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
SurgeoBite
K172978 · Surgovations, LLC · Dec 2017
EPIGUARD
K050188 · Episafe Medical Devices, Ltd. · Apr 2005
VENTIL-A ORAL PROTECTOR
K992269 · Somatics, Inc. · Oct 1999
UNIVERSAL BITE BLOCK
K960663 · B&B Medical Technologies, Inc. · May 1996