Cleared Traditional

K990240 - ELECTROGLOTTOGRAPH (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990240 · Kay Elemetrics Corp. · Ear, Nose, Throat device
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Mar 1999
Decision
45d
Days
Class 2
Risk

K990240 is an FDA 510(k) clearance for the ELECTROGLOTTOGRAPH. Classified as Electroglottograph (product code KLX), Class II - Special Controls.

Submitted by Kay Elemetrics Corp. (Lincoln Park, US). The FDA issued a Cleared decision on March 11, 1999 after a review of 45 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 Kay Elemetrics Corp. devices

Submission Details

510(k) Number K990240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1999
Decision Date March 11, 1999
Days to Decision 45 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 89d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.