Cleared Traditional

K871556 - MERIVAARA EMERGENCY PATIENT TROLLEY #436

K871556 is an FDA 510(k) clearance for MERIVAARA EMERGENCY PATIENT TROLLEY #436, manufactured by Global Medical Prods, Inc.. The device is a Class 2 General Hospital device with product code FPO cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K871556 · Global Medical Prods, Inc. · General Hospital
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Apr 1987
Decision
8d
Days
Class 2
Risk

K871556 is an FDA 510(k) clearance for the MERIVAARA EMERGENCY PATIENT TROLLEY #436. Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by Global Medical Prods, Inc. (Chicago, US). The FDA issued a Cleared decision on April 30, 1987 after a review of 8 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 Global Medical Prods, Inc. devices

FDA 510(k) Submission Details - K871556

510(k) Number K871556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1987
Decision Date April 30, 1987
Days to Decision 8 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 129d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FPO Stretcher, Wheeled

All 15
Devices cleared under the same product code (FPO) and FDA review panel - the closest regulatory comparables to K871556.
HILL-ROM VIA STRETCHER (P1300 - P1303)
K922808 · Hill-Rom, Inc. · Mar 1993
GENERAL PROCEDURAL STRETCHERS (P880- P886)
K922809 · Hill-Rom, Inc. · Mar 1993
MODEL #527 OPHTHALMIC STRETCHER
K904011 · Midmark Corp. · Oct 1990
KEYMED OFFICE COUCH
K854304 · Keymed, Inc. · Nov 1985
THE KEYMED VARI-HEIGHT PATIENT COUCH
K853421 · Keymed, Inc. · Sep 1985
CENTURIAN HYDRAULIC STRETCHER
K843439 · American Sterilizer Co. · Sep 1984