Cleared Traditional

BIOTRACE, MODEL 1730 (K002063) - FDA 510(k) Clearance

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

K002063 · Bryan Corp. · Neurology device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
34d
Days
Class 2
Risk

K002063 is an FDA 510(k) clearance for the BIOTRACE, MODEL 1730. Classified as Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty (product code MYU), Class II - Special Controls.

Submitted by Bryan Corp. (Woburn, US). The FDA issued a Cleared decision on August 10, 2000 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5300 - 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 Bryan Corp. devices

Submission Details

510(k) Number K002063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2000
Decision Date August 10, 2000
Days to Decision 34 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
114d faster than avg
Panel avg: 148d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MYU Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5300
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.