Cleared Traditional

K902503 - HARE FOLDING BACK EMERGENCY STRETCHER

K902503 is an FDA 510(k) clearance for HARE FOLDING BACK EMERGENCY STRETCHER, manufactured by Dyna Corp.. The device is a Class 2 General Hospital device with product code FPO cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K902503 · Dyna Corp. · General Hospital
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Jun 1990
Decision
21d
Days
Class 2
Risk

K902503 is an FDA 510(k) clearance for the HARE FOLDING BACK EMERGENCY STRETCHER. Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by Dyna Corp. (Carlsbad, US). The FDA issued a Cleared decision on June 26, 1990 after a review of 21 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 Dyna Corp. devices

FDA 510(k) Submission Details - K902503

510(k) Number K902503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1990
Decision Date June 26, 1990
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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 13
Devices cleared under the same product code (FPO) and FDA review panel - the closest regulatory comparables to K902503.
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