Cleared Traditional

K922692 - KINETIC TECHNOLOGY POCKET PRECISION ADJUSTOR

K922692 · Kinetic Technology, Inc. · Physical Medicine device
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Sep 1992
Decision
118d
Days
-
Risk

K922692 is an FDA 510(k) clearance for the KINETIC TECHNOLOGY POCKET PRECISION ADJUSTOR. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Kinetic Technology, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on September 30, 1992 after a review of 118 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 Kinetic Technology, Inc. devices

FDA 510(k) Submission Details - K922692

510(k) Number K922692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1992
Decision Date September 30, 1992
Days to Decision 118 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 115d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

LXM Device Classification - Class 0,

Product Code LXM Manipulator, Plunger-like Joint
Device Class -