Cleared Traditional

K800591 - CONTOUROGRAPH M-500 (FDA 510(k) Clearance)

K800591 · Bio-Tek Instruments, Inc. · Physical Medicine device
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Apr 1980
Decision
16d
Days
-
Risk

K800591 is an FDA 510(k) clearance for the CONTOUROGRAPH M-500. Classified as Device, Sensing, Optical Contour (product code LDK).

Submitted by Bio-Tek Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 2, 1980 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel. 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 Bio-Tek Instruments, Inc. devices

Submission Details

510(k) Number K800591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1980
Decision Date April 02, 1980
Days to Decision 16 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDK Device, Sensing, Optical Contour
Device Class -