Cleared Traditional

K823872 - EMERGENCY TRACHEOSTOMY KIT (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K823872 · Omnicon Medical Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1983
Decision
25d
Days
Class 1
Risk

K823872 is an FDA 510(k) clearance for the EMERGENCY TRACHEOSTOMY KIT. Classified as Chamber, Acoustic (for Audiometric Testing) (product code EWC), Class I - General Controls.

Submitted by Omnicon Medical Corp. (Walker, US). The FDA issued a Cleared decision on January 21, 1983 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Omnicon Medical Corp. devices

Submission Details

510(k) Number K823872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1982
Decision Date January 21, 1983
Days to Decision 25 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
64d faster than avg
Panel avg: 89d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EWC Chamber, Acoustic (for Audiometric Testing)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.1060
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.