Cleared Traditional

K942694 - STABILITY SYSTEM (110V) MODEL 945-300 (FDA 510(k) Clearance)

Also includes:
STABILITY SYSTEM (220V) MODEL #945-302

Class I Physical Medicine device.

K942694 · Biodex Medical Systems, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
276d
Days
Class 1
Risk

K942694 is an FDA 510(k) clearance for the STABILITY SYSTEM (110V) MODEL 945-300. Classified as Platform, Force-measuring (product code KHX), Class I - General Controls.

Submitted by Biodex Medical Systems, Inc. (Shirley, US). The FDA issued a Cleared decision on March 10, 1995 after a review of 276 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1575 - the FDA physical medicine device framework. 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 Biodex Medical Systems, Inc. devices

Submission Details

510(k) Number K942694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1994
Decision Date March 10, 1995
Days to Decision 276 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 115d · This submission: 276d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KHX Platform, Force-measuring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1575
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.