Cleared Traditional

K895016 - MODEL #510/515 GENERAL TRANSPORT STRETCHER

K895016 is an FDA 510(k) clearance for MODEL #510/515 GENERAL TRANSPORT STRETCHER, manufactured by Midmark Corp.. The device is a Class 1 Physical Medicine device with product code INW cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K895016 · Midmark Corp. · Physical Medicine device
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Sep 1989
Decision
34d
Days
Class 1
Risk

K895016 is an FDA 510(k) clearance for the MODEL #510/515 GENERAL TRANSPORT STRETCHER. Classified as Table, Mechanical (product code INW), Class I - General Controls.

Submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on September 11, 1989 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3750 - 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 - K895016

510(k) Number K895016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date September 11, 1989
Days to Decision 34 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 116d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

INW Device Classification - Class 1, General Controls

Product Code INW Table, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - INW Table, Mechanical

All 34
Devices cleared under the same product code (INW) and FDA review panel - the closest regulatory comparables to K895016.
GRASP (GRIGG-RUSSEL AIR SUPPORT PILLOW)
K901375 · Medical Plastics Laboratory, Inc. · Apr 1990
THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION
K895444 · Mcvicar Enterprises, Ltd. · Dec 1989
REFLUX BED
K896256 · Cozcon, Inc. · Nov 1989
MODEL #520/525 ED/RECOVERY STRETCHER
K894987 · Medmark, Inc. · Sep 1989
E653 OBLONG ABDUCTION BLOCK
K892697 · Rifton Equipment For the Handicapped · May 1989
E655 ADJUSTABLE ABDUCTION BLOCK W/HIP STABILIZER
K892698 · Rifton Equipment For the Handicapped · May 1989
K895016 · MODEL #510/515 GENERAL TRANSPORT STRETCHER
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