Cleared Traditional

K112502 - PROCEDURAL STRECHER WITH INTELLIDRIVE P8000

K112502 is an FDA 510(k) clearance for PROCEDURAL STRECHER WITH INTELLIDRIVE P8000, manufactured by Hill-Rom Co.. The device is a Class 2 Physical Medicine device with product code INK cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K112502 · Hill-Rom Co. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
20d
Days
Class 2
Risk

K112502 is an FDA 510(k) clearance for the PROCEDURAL STRECHER WITH INTELLIDRIVE P8000. Classified as Stretcher, Wheeled, Powered (product code INK), Class II - Special Controls.

Submitted by Hill-Rom Co. (Batesville, US). The FDA issued a Cleared decision on September 19, 2011 after a review of 20 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K112502

510(k) Number K112502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2011
Decision Date September 19, 2011
Days to Decision 20 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
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
96d faster than avg
Panel avg: 116d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
PAULA WILKERSON

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 - INK Stretcher, Wheeled, Powered

All 9
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FDA 510(k) Resources - Physical Medicine

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

K112502 · PROCEDURAL STRECHER WITH INTELLIDRIVE P8000
Download PDF FDA Summary Hill-Rom Co.