Cleared Traditional

SUPER SILIPLUGS EAR PLUGS (K972923) - FDA 510(k) Clearance

K972923 · Interview Medical Technology Corp. · Ear, Nose, Throat device
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Oct 1997
Decision
80d
Days
-
Risk

K972923 is an FDA 510(k) clearance for the SUPER SILIPLUGS EAR PLUGS. Classified as Protector, Hearing (insert) (product code EWD).

Submitted by Interview Medical Technology Corp. (El Dorado Hills, US). The FDA issued a Cleared decision on October 27, 1997 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel. 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 Interview Medical Technology Corp. devices

Submission Details

510(k) Number K972923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1997
Decision Date October 27, 1997
Days to Decision 80 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
9d faster than avg
Panel avg: 89d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EWD Protector, Hearing (insert)
Device Class -