Cleared Traditional

K844736 - ISIS

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

FDA 510(k) Submission Details - K844736

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

LDK Device Classification - Class 0,

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