Cleared Traditional

K022309 - STRYKER POWERED WHEELED STRETCHER (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022309 · Stryker Corp. · Physical Medicine device
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Nov 2002
Decision
115d
Days
Class 2
Risk

K022309 is an FDA 510(k) clearance for the STRYKER POWERED WHEELED STRETCHER. Classified as Stretcher, Wheeled, Powered (product code INK), Class II - Special Controls.

Submitted by Stryker Corp. (Washington, US). The FDA issued a Cleared decision on November 8, 2002 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3690 - 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 K022309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2002
Decision Date November 08, 2002
Days to Decision 115 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
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code INK Stretcher, Wheeled, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.