Cleared Traditional

PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 (K112502) - FDA 510(k) Clearance

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

K112502 · Hill-Rom Co. · Physical Medicine device
Download Printable Device Report (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.

View all Hill-Rom Co. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
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.