Cleared Traditional

K873992 - LARYNGECTOMY TUBE

K873992 is an FDA 510(k) clearance for LARYNGECTOMY TUBE, manufactured by Portex, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code KAC cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K873992 · Portex, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K873992

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 89d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

KAC Device Classification - Class 1, General Controls

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.