Cleared Traditional

K041985 - XPS CURVED BUR

K041985 is an FDA 510(k) clearance for XPS CURVED BUR, manufactured by Medtronic Xomed, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code EQJ cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K041985 · Medtronic Xomed, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K041985

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
Combination Product No
PCCP Authorized No
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.

EQJ Device Classification - Class 1, General Controls

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.

Regulatory Consultant

Underwriters Laboratories, Inc.
WILLIAM J SAMMONS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EQJ Bur, Ear, Nose And Throat

All 9
Devices cleared under the same product code (EQJ) and FDA review panel - the closest regulatory comparables to K041985.
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ACE SYSTEM
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KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL
K950337 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
ESSENTIAL SHAVER SYSTEM
K953096 · Smith & Nephew Richards, Inc. · Jul 1995

FDA 510(k) Resources - Ear, Nose, Throat

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.