Cleared Traditional

TERRAN BIOMECHANICAL ANALYSIS SYSTEM (K851133) - FDA 510(k) Clearance

K851133 · Terran Biomedical Instruments · Physical Medicine device
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Jun 1985
Decision
90d
Days
-
Risk

K851133 is an FDA 510(k) clearance for the TERRAN BIOMECHANICAL ANALYSIS SYSTEM. Classified as Device, Sensing, Optical Contour (product code LDK).

Submitted by Terran Biomedical Instruments (Salem, US). The FDA issued a Cleared decision on June 19, 1985 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K851133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1985
Decision Date June 19, 1985
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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