Cleared Traditional

K800445 - EDINBURGH MASKER

K800445 is an FDA 510(k) clearance for EDINBURGH MASKER, manufactured by Foundation For Fluency, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code KTH cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K800445 · Foundation For Fluency, Inc. · Ear, Nose, Throat device
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Mar 1980
Decision
13d
Days
Class 1
Risk

K800445 is an FDA 510(k) clearance for the EDINBURGH MASKER. Classified as Device, Anti-stammering (product code KTH), Class I - General Controls.

Submitted by Foundation For Fluency, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1980 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5840 - 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 Foundation For Fluency, Inc. devices

FDA 510(k) Submission Details - K800445

510(k) Number K800445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1980
Decision Date March 12, 1980
Days to Decision 13 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
76d faster than avg
Panel avg: 89d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

KTH Device Classification - Class 1, General Controls

Product Code KTH Device, Anti-stammering
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5840
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.