Cleared Traditional

K840907 - POST-AID

K840907 is an FDA 510(k) clearance for POST-AID, manufactured by E.W. Link, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code KCM cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K840907 · E.W. Link, Inc. · Ear, Nose, Throat device
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Aug 1984
Decision
156d
Days
Class 1
Risk

K840907 is an FDA 510(k) clearance for the POST-AID. Classified as Dropper, Ent (product code KCM), Class I - General Controls.

Submitted by E.W. Link, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1984 after a review of 156 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5220 - 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 E.W. Link, Inc. devices

FDA 510(k) Submission Details - K840907

510(k) Number K840907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1984
Decision Date August 02, 1984
Days to Decision 156 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
67d slower than avg
Panel avg: 89d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

KCM Device Classification - Class 1, General Controls

Product Code KCM Dropper, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5220
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.