Cleared Traditional

K964073 - BME BONE DRILL BITS (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K964073 · Biomedical Ent., Inc. · General & Plastic Surgery device
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Nov 1996
Decision
34d
Days
Class 1
Risk

K964073 is an FDA 510(k) clearance for the BME BONE DRILL BITS. Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by Biomedical Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on November 14, 1996 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - the FDA general and plastic surgery 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 Biomedical Ent., Inc. devices

Submission Details

510(k) Number K964073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1996
Decision Date November 14, 1996
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 114d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEY Motor, Surgical Instrument, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.