Cleared Traditional

K014060 - MICROAIRE 1000E SYSTEM

K014060 is an FDA 510(k) clearance for MICROAIRE 1000E SYSTEM, manufactured by Microaire Surgical Instruments, Inc.. The device is a Class 2 Neurology device with product code HBE cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K014060 · Microaire Surgical Instruments, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
85d
Days
Class 2
Risk

K014060 is an FDA 510(k) clearance for the MICROAIRE 1000E SYSTEM. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Microaire Surgical Instruments, Inc. (Charlottesville, US). The FDA issued a Cleared decision on March 5, 2002 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - 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 Microaire Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K014060

510(k) Number K014060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2001
Decision Date March 05, 2002
Days to Decision 85 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
63d faster than avg
Panel avg: 148d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBE Device Classification - Class 2, Special Controls

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
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 - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 43
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K014060.
ANSPACH ADVANCED MICRO SAW ATTACHMENTS
K040076 · The Anspach Effort, Inc. · Mar 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K032303 · Stryker Instruments · Jan 2004
CRANIOCUT
K022942 · Aesculap, Inc. · Oct 2002
ANSPACH ANGLED MICRONOSE ATTACHMENT
K002903 · The Anspach Effort, Inc. · Oct 2000
75K STAIGHT DRILL
K943541 · Stryker Corp. · May 1995
MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
K903664 · Micro-Aire Surgical Instruments, Inc. · Sep 1990