Cleared Traditional

K943529 - PATIENT TROLLEY 540

K943529 is an FDA 510(k) clearance for PATIENT TROLLEY 540, manufactured by Merivaara Instrumentarium Corp.. The device is a Class 2 General Hospital device with product code FPO cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K943529 · Merivaara Instrumentarium Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
75d
Days
Class 2
Risk

K943529 is an FDA 510(k) clearance for the PATIENT TROLLEY 540. Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by Merivaara Instrumentarium Corp. (Washington, US). The FDA issued a Cleared decision on October 4, 1994 after a review of 75 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 Merivaara Instrumentarium Corp. devices

FDA 510(k) Submission Details - K943529

510(k) Number K943529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1994
Decision Date October 04, 1994
Days to Decision 75 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 129d · This submission: 75d
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 17
Devices cleared under the same product code (FPO) and FDA review panel - the closest regulatory comparables to K943529.
HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER
K952447 · Hill-Rom, Inc. · Nov 1995
EMERGENCY/ACCIDENT TROLLEY 550
K946101 · Hogan & Hartson · Feb 1995
STRYKER POWERED STRETCHER
K942948 · Stryker Corp. · Jan 1995
MODEL 561 C-ARM PROCEDURES STRETCHER
K923730 · Midmark Corp. · Feb 1994
HILL-ROM VIA STRETCHER (P1300 - P1303)
K922808 · Hill-Rom, Inc. · Mar 1993
GENERAL PROCEDURAL STRETCHERS (P880- P886)
K922809 · Hill-Rom, Inc. · Mar 1993