Cleared Traditional

MEDCO CUSTOM EAR PROTECTOR MOLD KIT (K821187) - FDA 510(k) Clearance

K821187 · Santa Barbara Medco, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1982
Decision
30d
Days
-
Risk

K821187 is an FDA 510(k) clearance for the MEDCO CUSTOM EAR PROTECTOR MOLD KIT. Classified as Protector, Hearing (insert) (product code EWD).

Submitted by Santa Barbara Medco, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1982 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 Santa Barbara Medco, Inc. devices

Submission Details

510(k) Number K821187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date May 27, 1982
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 -