Cleared Traditional

K002990 - VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000 (FDA 510(k) Clearance)

Also includes:
VTI SKULL SCREW, MODEL 22001

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K002990 · Vascular Technology Incorporated · Neurology device
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Nov 2000
Decision
42d
Days
Class 2
Risk

K002990 is an FDA 510(k) clearance for the VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Vascular Technology Incorporated (Lowell, US). The FDA issued a Cleared decision on November 6, 2000 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - 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 Vascular Technology Incorporated devices

Submission Details

510(k) Number K002990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2000
Decision Date November 06, 2000
Days to Decision 42 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 148d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
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 - HBL Holder, Head, Neurosurgical (skull Clamp)

All 49
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