Cleared Traditional

PRO-MOLD, CUSTOM EAR (K781491) - FDA 510(k) Clearance

K781491 · Mcghan Medical Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1978
Decision
30d
Days
-
Risk

K781491 is an FDA 510(k) clearance for the PRO-MOLD, CUSTOM EAR. Classified as Protector, Hearing (insert) (product code EWD).

Submitted by Mcghan Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1978 after a review of 30 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 Mcghan Medical Corp. devices

Submission Details

510(k) Number K781491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1978
Decision Date September 27, 1978
Days to Decision 30 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
59d faster than avg
Panel avg: 89d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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