Cleared Traditional

K821079 - ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG

K821079 is an FDA 510(k) clearance for ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG, manufactured by Ms. Kate Teaney. The device is a Class 2 Ear, Nose, Throat device with product code KLX cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K821079 · Ms. Kate Teaney · Ear, Nose, Throat device
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May 1982
Decision
21d
Days
Class 2
Risk

K821079 is an FDA 510(k) clearance for the ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG. Classified as Electroglottograph (product code KLX), Class II - Special Controls.

Submitted by Ms. Kate Teaney (Walker, US). The FDA issued a Cleared decision on May 10, 1982 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1325 - 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 Ms. Kate Teaney devices

FDA 510(k) Submission Details - K821079

510(k) Number K821079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1982
Decision Date May 10, 1982
Days to Decision 21 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
68d faster than avg
Panel avg: 89d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLX Device Classification - Class 2, Special Controls

Product Code KLX Electroglottograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1325
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.