Cleared Traditional

K781907 - EAR STOPPLES FOR NOISE ATTENTION (FDA 510(k) Clearance)

K781907 · Crown Delta Corp. · Ear, Nose, Throat device
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Nov 1978
Decision
8d
Days
-
Risk

K781907 is an FDA 510(k) clearance for the EAR STOPPLES FOR NOISE ATTENTION. Classified as Protector, Hearing (insert) (product code EWD).

Submitted by Crown Delta Corp. (Walker, US). The FDA issued a Cleared decision on November 22, 1978 after a review of 8 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 Crown Delta Corp. devices

Submission Details

510(k) Number K781907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1978
Decision Date November 22, 1978
Days to Decision 8 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
81d faster than avg
Panel avg: 89d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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