Cleared Traditional

K844736 - ISIS (FDA 510(k) Clearance)

K844736 · Oxford Medilog, Inc. · Physical Medicine device
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Mar 1985
Decision
106d
Days
-
Risk

K844736 is an FDA 510(k) clearance for the ISIS. Classified as Device, Sensing, Optical Contour (product code LDK).

Submitted by Oxford Medilog, Inc. (Clearwater, US). The FDA issued a Cleared decision on March 21, 1985 after a review of 106 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.

View all Oxford Medilog, Inc. devices

Submission Details

510(k) Number K844736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1984
Decision Date March 21, 1985
Days to Decision 106 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
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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