Cleared Traditional

K011444 - ANSPACH EMAX DRILL SYSTEM

K011444 is the FDA 510(k) clearance for ANSPACH EMAX DRILL SYSTEM by The Anspach Effort, Inc.. It is a Class 2 Neurology device (product code HBC) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K011444 · The Anspach Effort, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
89d
Days
Class 2
Risk

K011444 is an FDA 510(k) clearance for the ANSPACH EMAX DRILL SYSTEM. Classified as Motor, Drill, Electric (product code HBC), Class II - Special Controls.

Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on August 8, 2001 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4360 - 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 The Anspach Effort, Inc. devices

Submission Details

510(k) Number K011444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2001
Decision Date August 08, 2001
Days to Decision 89 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 148d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBC Motor, Drill, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4360
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 - HBC Motor, Drill, Electric

All 15
Devices cleared under the same product code (HBC) and FDA review panel - the closest regulatory comparables to K011444.
PRIMADO
K083112 · Nakanishi, Inc. · Apr 2009
MICROPOWER HAND PIECE HIGH SPEED DRILL
K060260 · Linvatec Corp. · Apr 2006
MICROSPEED UNI MOTOR SYSTEM
K053526 · Aesculap, Inc. · Jan 2006
MICROSPEED EC MOTORSYSTEM GD650/GD653
K003612 · Aesculap, Inc. · Feb 2001
ADVANTAGE DRIVE SYSTEM
K002523 · Linvatec Corp. · Oct 2000