Cleared Traditional

K900671 - HARE EMERGENCY STRETCHER WITH WHEELS

K900671 is an FDA 510(k) clearance for HARE EMERGENCY STRETCHER WITH WHEELS, manufactured by Dyna Corp.. The device is a Class 1 General Hospital device with product code FPP cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K900671 · Dyna Corp. · General Hospital
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Apr 1990
Decision
69d
Days
Class 1
Risk

K900671 is an FDA 510(k) clearance for the HARE EMERGENCY STRETCHER WITH WHEELS. Classified as Stretcher, Hand-carried (product code FPP), Class I - General Controls.

Submitted by Dyna Corp. (Carlsbad, US). The FDA issued a Cleared decision on April 23, 1990 after a review of 69 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6900 - 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 - K900671

510(k) Number K900671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1990
Decision Date April 23, 1990
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

FPP Device Classification - Class 1, General Controls

Product Code FPP Stretcher, Hand-carried
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6900
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 - FPP Stretcher, Hand-carried

All 36
Devices cleared under the same product code (FPP) and FDA review panel - the closest regulatory comparables to K900671.
LITTER, FOLDING RIGID POLE, DECONTAMINABLE
K901760 · Dept. of the Army · Jul 1990
WEEVAC 6 INFANT EVACUATION STRETCHER
K902521 · W. Murphy Ent., Inc. · Jun 1990
HARE EMERGENCY STRETCHER
K900670 · Dyna Corp. · Apr 1990
SKED STRETCHER
K896177 · Skedco, Inc. · Jan 1990
SKED FLOTATION SYSTEM
K896179 · Skedco, Inc. · Jan 1990
THE SMITHCOT
K896261 · Ram Marketing, Inc. · Dec 1989
K900671 · HARE EMERGENCY STRETCHER WITH WHEELS
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