Cleared Traditional

K812744 - LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER

K812744 is the FDA 510(k) clearance for LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER by Progress Mankind Technology. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K812744 · Progress Mankind Technology · Neurology device
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Dec 1981
Decision
65d
Days
Class 2
Risk

K812744 is an FDA 510(k) clearance for the LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Progress Mankind Technology (Hopkins, US). The FDA issued a Cleared decision on December 3, 1981 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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 Progress Mankind Technology devices

Submission Details

510(k) Number K812744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1981
Decision Date December 03, 1981
Days to Decision 65 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 148d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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.