Cleared Traditional

K862959 - MERIVAARA PATIENT TROLLEY - MODEL #416

K862959 is an FDA 510(k) clearance for MERIVAARA PATIENT TROLLEY - MODEL #416, 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 51-day FDA review.

K862959 · Global Medical Prods, Inc. · General Hospital
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Sep 1986
Decision
51d
Days
Class 2
Risk

K862959 is an FDA 510(k) clearance for the MERIVAARA PATIENT TROLLEY - MODEL #416. 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 September 25, 1986 after a review of 51 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.

FDA 510(k) Submission Details - K862959

510(k) Number K862959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1986
Decision Date September 25, 1986
Days to Decision 51 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 129d · This submission: 51d
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 42
Devices cleared under the same product code (FPO) and FDA review panel - the closest regulatory comparables to K862959.
STRETCHER, WHEELED, MECHANICAL
K873181 · Cambridge Technologies, Inc. · Oct 1987
MERIVAARA EMERGENCY PATIENT TROLLEY #436
K871556 · Global Medical Prods, Inc. · Apr 1987
MODEL 35-B ALL LEVEL COT
K864269 · Ferno-Washington, Inc. · Nov 1986
EZ LOAD MODEL 30, ALL LEVEL COT
K862441 · Ferno-Washington, Inc. · Sep 1986
BETA MEDICAL PRODUCTS EMR-301 HYDRAULIC STRETCHER
K863083 · Beta Medical Products Co. · Sep 1986
LIC MOBILE TRANSPORT STRETCHERS
K861410 · Lada Intl., Inc. · Apr 1986
K862959 · MERIVAARA PATIENT TROLLEY - MODEL #416
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