Cleared Traditional

K140095 - PRIME ZOOM STRETCHER (FDA 510(k) Clearance)

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

K140095 · Stryker Corporation · Physical Medicine device
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May 2014
Decision
126d
Days
Class 2
Risk

K140095 is an FDA 510(k) clearance for the PRIME ZOOM STRETCHER. Classified as Stretcher, Wheeled, Powered (product code INK), Class II - Special Controls.

Submitted by Stryker Corporation (Portage, US). The FDA issued a Cleared decision on May 20, 2014 after a review of 126 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.

View all Stryker Corporation devices

Submission Details

510(k) Number K140095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2014
Decision Date May 20, 2014
Days to Decision 126 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.