Cleared Traditional

K042974 - MEDICON VIPAIR HIGH SPEED SYSTEM

K042974 is an FDA 510(k) clearance for MEDICON VIPAIR HIGH SPEED SYSTEM, manufactured by Medicon EG. The device is a Class 2 Neurology device with product code HBB cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K042974 · Medicon EG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
77d
Days
Class 2
Risk

K042974 is an FDA 510(k) clearance for the MEDICON VIPAIR HIGH SPEED SYSTEM. Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Medicon EG (Tuttlingen, DE). The FDA issued a Cleared decision on January 13, 2005 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4370 - the FDA neurology 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 Medicon EG devices

FDA 510(k) Submission Details - K042974

510(k) Number K042974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2004
Decision Date January 13, 2005
Days to Decision 77 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 148d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBB Device Classification - Class 2, Special Controls

Product Code HBB Motor, Drill, Pneumatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4370
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 Neurology devices follow this clearance model.

Regulatory Peers - HBB Motor, Drill, Pneumatic

All 13
Devices cleared under the same product code (HBB) and FDA review panel - the closest regulatory comparables to K042974.
SYNTHES AIR PEN DRIVE (APD) SYSTEM
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ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
K061297 · The Anspach Effort, Inc. · Jan 2007
STRYKER ARIA PNEUMATIC SYSTEM
K061725 · Stryker Instruments · Oct 2006
STRYKER MAESTRO SYSTEM
K041754 · Stryker Corp. · Sep 2004
ANSPACH MRI SAFE SURGICAL DRILL SYSTEM
K040186 · The Anspach Effort, Inc. · Apr 2004
CRANIAL DRILL
K000195 · Image-Guided Neurologics, Inc. · Apr 2000