Cleared Traditional

DOC'S PROPLUGS EAR PLUGS (K862045) - FDA 510(k) Clearance

K862045 · Doc'S Proplugs, Inc. · Ear, Nose, Throat device
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Apr 1987
Decision
317d
Days
-
Risk

K862045 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 April 10, 1987 after a review of 317 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 K862045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1986
Decision Date April 10, 1987
Days to Decision 317 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
228d slower than avg
Panel avg: 89d · This submission: 317d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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