Cleared Traditional

K153270 - TruGuard Custom Tongue and Jaw Positioner

K153270 is the FDA 510(k) clearance for TruGuard Custom Tongue and Jaw Positioner by Bionix Development Corp.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K153270 · Bionix Development Corp. · Radiology device
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Mar 2016
Decision
117d
Days
Class 2
Risk

K153270 is an FDA 510(k) clearance for the TruGuard Custom Tongue and Jaw Positioner. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Bionix Development Corp. (Toledo, US). The FDA issued a Cleared decision on March 8, 2016 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bionix Development Corp. devices

Submission Details

510(k) Number K153270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2015
Decision Date March 08, 2016
Days to Decision 117 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 107d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

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