Cleared Traditional

K874412 - THE PROTECTOR (FDA 510(k) Clearance)

Class I Anesthesiology device.

K874412 · Tri Jon, Inc. · Anesthesiology device
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Feb 1988
Decision
107d
Days
Class 1
Risk

K874412 is an FDA 510(k) clearance for the THE PROTECTOR. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Tri Jon, Inc. (Arlington, US). The FDA issued a Cleared decision on February 12, 1988 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5110 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tri Jon, Inc. devices

Submission Details

510(k) Number K874412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date February 12, 1988
Days to Decision 107 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 139d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAE Airway, Oropharyngeal, Anesthesiology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5110
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.