Cleared Traditional

DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER (K893254) - FDA 510(k) Clearance

Class I Physical Medicine device.

K893254 · Dalphi, Inc. · Physical Medicine device
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Jan 1990
Decision
249d
Days
Class 1
Risk

K893254 is an FDA 510(k) clearance for the DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER. Classified as Platform, Force-measuring (product code KHX), Class I - General Controls.

Submitted by Dalphi, Inc. (Washington, US). The FDA issued a Cleared decision on January 2, 1990 after a review of 249 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 Dalphi, Inc. devices

Submission Details

510(k) Number K893254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1989
Decision Date January 02, 1990
Days to Decision 249 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
134d slower than avg
Panel avg: 115d · This submission: 249d
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.