Cleared Traditional

K041985 - XPS CURVED BUR (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K041985 · Medtronic Xomed, Inc. · Ear, Nose, Throat device
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Aug 2004
Decision
20d
Days
Class 1
Risk

K041985 is an FDA 510(k) clearance for the XPS CURVED BUR. Classified as Bur, Ear, Nose And Throat (product code EQJ), Class I - General Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 12, 2004 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4140 - the FDA ear, nose and throat device framework. 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 Medtronic Xomed, Inc. devices

Submission Details

510(k) Number K041985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2004
Decision Date August 12, 2004
Days to Decision 20 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 89d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code EQJ Bur, Ear, Nose And Throat
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4140
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.