Cleared Traditional

KINETIC TECHNOLOGY PRECISION ADUSTOR MODEL SHLCP-4 (K922694) - FDA 510(k) Clearance

K922694 · Kinetic Technology, Inc. · Physical Medicine device
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Sep 1992
Decision
118d
Days
-
Risk

K922694 is an FDA 510(k) clearance for the KINETIC TECHNOLOGY PRECISION ADUSTOR MODEL SHLCP-4. 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

Submission Details

510(k) Number K922694 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.

Device Classification

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