Cleared Traditional

K073401 - EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 (FDA 510(k) Clearance)

K073401 · Micromedics, Inc. · Ear, Nose, Throat device
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Mar 2008
Decision
101d
Days
-
Risk

K073401 is an FDA 510(k) clearance for the EARPOPPER, MODEL EP-2000, EP-2100, EP-3000. Classified as Device, Inflation, Middle Ear within the MJV classification (a niche ENT category for middle ear pressure regulation devices).

Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 14, 2008 after a review of 101 days - within the typical 510(k) review window.

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. Standard predicate reliance. Middle ear inflation devices represent a low-volume ENT category with limited predicate history - the 165-day review reflects the FDA's careful equivalence assessment for this specialized device type.

View all Micromedics, Inc. devices

Submission Details

510(k) Number K073401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2007
Decision Date March 14, 2008
Days to Decision 101 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 89d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MJV Device, Inflation, Middle Ear
Device Class -