Cleared Traditional

K113598 - POWER-LOAD COT FASTENER SYSTEM

K113598 is an FDA 510(k) clearance for POWER-LOAD COT FASTENER SYSTEM, manufactured by Stryker Medical. The device is a Class 2 General Hospital device with product code FPO cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K113598 · Stryker Medical · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 2011
Decision
15d
Days
Class 2
Risk

K113598 is an FDA 510(k) clearance for the POWER-LOAD COT FASTENER SYSTEM. Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by Stryker Medical (Portage, US). The FDA issued a Cleared decision on December 20, 2011 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6910 - the FDA general hospital 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Medical devices

FDA 510(k) Submission Details - K113598

510(k) Number K113598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2011
Decision Date December 20, 2011
Days to Decision 15 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FPO Device Classification - Class 2, Special Controls

Product Code FPO Stretcher, Wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6910
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 General Hospital devices follow this clearance model.

Regulatory Consultant

Intertek Testing Services
BHAVESH V SHETH

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FPO Stretcher, Wheeled

All 16
Devices cleared under the same product code (FPO) and FDA review panel - the closest regulatory comparables to K113598.
IRSG I-MOVER FOR BEDS
K072598 · International Retail Services Group, LLC · Apr 2008
DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)
K972528 · Dyna Corp. · Jul 1997
ADULT-PEDIATRIC TRANSPORT SYSTEM
K955766 · International Biomedical, Inc. · Aug 1996
HARE MODEL 2000 EZ LOADER MODEL 95555
K962181 · Dyna Corp. · Aug 1996
WHEELED STRETCHER
K961437 · Hill-Rom, Inc. · Jun 1996
HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER
K952447 · Hill-Rom, Inc. · Nov 1995

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.