Cleared Traditional

K920526 - STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500 (FDA 510(k) Clearance)

Class I Physical Medicine device.

K920526 · Stryker Medical · Physical Medicine device
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Sep 1992
Decision
230d
Days
Class 1
Risk

K920526 is an FDA 510(k) clearance for the STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500. Classified as Treadmill, Mechanical (product code IOG), Class I - General Controls.

Submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on September 21, 1992 after a review of 230 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5370 - 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.

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Submission Details

510(k) Number K920526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1992
Decision Date September 21, 1992
Days to Decision 230 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
115d slower than avg
Panel avg: 115d · This submission: 230d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IOG Treadmill, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5370
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.