Cleared Traditional

K892866 - AUTOMATIC CRANIAL DRILL (PERFORATOR)

K892866 is the FDA 510(k) clearance for AUTOMATIC CRANIAL DRILL (PERFORATOR) by Acra Cut, Inc.. It is a Class 2 Neurology device (product code HBF) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K892866 · Acra Cut, Inc. · Neurology device
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Jun 1989
Decision
57d
Days
Class 2
Risk

K892866 is an FDA 510(k) clearance for the AUTOMATIC CRANIAL DRILL (PERFORATOR). Classified as Drills, Burrs, Trephines & Accessories (compound, Powered) (product code HBF), Class II - Special Controls.

Submitted by Acra Cut, Inc. (Acton, US). The FDA issued a Cleared decision on June 15, 1989 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4305 - 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 Acra Cut, Inc. devices

Submission Details

510(k) Number K892866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1989
Decision Date June 15, 1989
Days to Decision 57 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 148d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBF Drills, Burrs, Trephines & Accessories (compound, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4305
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 - HBF Drills, Burrs, Trephines & Accessories (compound, Powered)

All 11
Devices cleared under the same product code (HBF) and FDA review panel - the closest regulatory comparables to K892866.
ANSPACH ACCESS CRANIAL PERFORATOR
K982991 · The Anspach Effort, Inc. · Oct 1998
DISPOSABLE PERFORATOR
K933894 · Codman & Shurtleff, Inc. · Dec 1993
DISPOSABLE PERFORATOR
K924242 · Codman & Shurtleff, Inc. · Jul 1993
CODMAN * REUSABLE PERFORATOR
K820087 · Codman & Shurtleff, Inc. · Feb 1982
DISPOSABLE PERFORATORS, JACOBS, HUDSON
K791101 · Codman & Shurtleff, Inc. · Aug 1979