Cleared Traditional

ELASTO-GEL CAST & SPLINT PADS (K872488) - FDA 510(k) Clearance

Class I Physical Medicine device.

K872488 · Southwest Technologies, Inc. · Physical Medicine device
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Sep 1987
Decision
90d
Days
Class 1
Risk

K872488 is an FDA 510(k) clearance for the ELASTO-GEL CAST & SPLINT PADS. Classified as Cover, Limb (product code IPM), Class I - General Controls.

Submitted by Southwest Technologies, Inc. (Kansas City, US). The FDA issued a Cleared decision on September 21, 1987 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3025 - 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 Southwest Technologies, Inc. devices

Submission Details

510(k) Number K872488 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 23, 1987
Decision Date September 21, 1987
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IPM Cover, Limb
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3025
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.