Cleared Traditional

DOC'S PROPLUGS EAR PLUGS (K945376) - FDA 510(k) Clearance

K945376 · Doc'S Proplugs, Inc. · Ear, Nose, Throat device
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Nov 1995
Decision
389d
Days
-
Risk

K945376 is an FDA 510(k) clearance for the DOC'S PROPLUGS EAR PLUGS. Classified as Protector, Hearing (insert) (product code EWD).

Submitted by Doc'S Proplugs, Inc. (Santa Cruz, US). The FDA issued a Cleared decision on November 14, 1995 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Doc'S Proplugs, Inc. devices

Submission Details

510(k) Number K945376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1994
Decision Date November 14, 1995
Days to Decision 389 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
300d slower than avg
Panel avg: 89d · This submission: 389d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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