Cleared Traditional

K021098 - DAUM-LECTRIC MRI DRILLING MACHINE

K021098 is an FDA 510(k) clearance for DAUM-LECTRIC MRI DRILLING MACHINE, manufactured by Mri Devices Daum GmbH. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K021098 · Mri Devices Daum GmbH · Ear, Nose, Throat device
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Dec 2002
Decision
243d
Days
Class 2
Risk

K021098 is an FDA 510(k) clearance for the DAUM-LECTRIC MRI DRILLING MACHINE. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Mri Devices Daum GmbH (Crofton,, US). The FDA issued a Cleared decision on December 3, 2002 after a review of 243 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K021098

510(k) Number K021098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2002
Decision Date December 03, 2002
Days to Decision 243 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 90d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ERL Device Classification - Class 2, Special Controls

Product Code ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

All 83
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K021098.
DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
K034004 · Gyrus Ent LLC · Mar 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
K040300 · Stryker Instruments · Mar 2004
SODEM HIGH SPEED SYSTEM (PNEUMATIC)
K023070 · Sodemsystems · Jan 2003
UNIDRIVE II PLUS DISPOSABLE TUBING SET
K021811 · Mtp Medical Technical Promotion GmbH · Jun 2002
DIEGO POWERED DISSECTOR AND DRILL SYSTEM
K020594 · Gyrus Ent LLC · Mar 2002
SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
K012456 · Sodemsystems · Sep 2001
K021098 · DAUM-LECTRIC MRI DRILLING MACHINE
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