Cleared Traditional

K822618 - EMERGENCY TRACHEOSTOMY INSTRUMENT SET

K822618 is an FDA 510(k) clearance for EMERGENCY TRACHEOSTOMY INSTRUMENT SET, manufactured by Kelleher Corp.. The device is a Class 1 Ear, Nose, Throat device with product code LJW cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K822618 · Kelleher Corp. · Ear, Nose, Throat device
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Jan 1983
Decision
148d
Days
Class 1
Risk

K822618 is an FDA 510(k) clearance for the EMERGENCY TRACHEOSTOMY INSTRUMENT SET. Classified as Tracheotome (product code LJW), Class I - General Controls.

Submitted by Kelleher Corp. (Richmond, US). The FDA issued a Cleared decision on January 28, 1983 after a review of 148 days - within the typical 510(k) review window.

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 Kelleher Corp. devices

FDA 510(k) Submission Details - K822618

510(k) Number K822618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1982
Decision Date January 28, 1983
Days to Decision 148 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
58d slower than avg
Panel avg: 90d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

LJW Device Classification - Class 1, General Controls

Product Code LJW Tracheotome
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.