Cleared Traditional

K874412 - THE PROTECTOR

K874412 is an FDA 510(k) clearance for THE PROTECTOR, manufactured by Tri Jon, Inc.. The device is a Class 1 Anesthesiology device with product code CAE cleared through the Traditional 510(k) pathway after a 107-day FDA review.

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.

FDA 510(k) Submission Details - K874412

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
33d faster than avg
Panel avg: 140d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

CAE Device Classification - Class 1, General Controls

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.

Regulatory Peers - CAE Airway, Oropharyngeal, Anesthesiology

All 26
Devices cleared under the same product code (CAE) and FDA review panel - the closest regulatory comparables to K874412.
GUEDEL AIRWAY
K922748 · Oem Medical Div. · Jul 1992
INTAVENT LARYNGEAL MASK
K904834 · Intavent Intl. S.A. · Jul 1991
ORAL AIRWAY
K891586 · Dynarex Corp. · May 1989
DUAL-AID
K860949 · Vitalograph , Ltd. · May 1986
DISPOSABLE BERMAN AND GUEDEL AIRWAYS
K861540 · Dryden Corp. · May 1986
DISPOSABLE RESCUE BREATHING DEVICE
K861054 · B & F Medical Products, Inc. · Apr 1986
K874412 · THE PROTECTOR
Download PDF Tri Jon, Inc.