Cleared Traditional

K022309 - STRYKER POWERED WHEELED STRETCHER

K022309 is an FDA 510(k) clearance for STRYKER POWERED WHEELED STRETCHER, manufactured by Stryker Corp.. The device is a Class 2 Physical Medicine device with product code INK cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K022309 · Stryker Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K022309

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 116d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - INK Stretcher, Wheeled, Powered

All 11
Devices cleared under the same product code (INK) and FDA review panel - the closest regulatory comparables to K022309.
POWER DRIVE CHAIR, MODEL: TMM6
K091043 · Transmotion Medical, Inc. · May 2009
THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777
K051861 · Savion Industries, Ltd. · Sep 2005
HAUSTED POWERTRAN SERIES STRETCHER
K041924 · STERIS Corporation · Sep 2004
ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE
K912175 · Isotechnologies, Inc. · Jun 1991
MODELS 134, 135 & 136 TRANSFER CART/TABLE
K844711 · Tri W-G, Inc. · Mar 1985
TRANS 2000
K771018 · Hamilton Industries, Inc. · Jul 1977
K022309 · STRYKER POWERED WHEELED STRETCHER
Download PDF FDA Summary Stryker Corp.