Cleared Traditional

K873992 - LARYNGECTOMY TUBE (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K873992 · Portex, Inc. · Ear, Nose, Throat device
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Mar 1988
Decision
175d
Days
Class 1
Risk

K873992 is an FDA 510(k) clearance for the LARYNGECTOMY TUBE. Classified as Tube, Laryngectomy (product code KAC), Class I - General Controls.

Submitted by Portex, Inc. (Wilmington, US). The FDA issued a Cleared decision on March 24, 1988 after a review of 175 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Portex, Inc. devices

Submission Details

510(k) Number K873992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1987
Decision Date March 24, 1988
Days to Decision 175 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 89d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KAC Tube, Laryngectomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.