Cleared Traditional

K972528 - DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)

K972528 is an FDA 510(k) clearance for DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (..., 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.

K972528 · Dyna Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 1997
Decision
21d
Days
Class 2
Risk

K972528 is an FDA 510(k) clearance for the DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759). Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by Dyna Corp. (Carlsbad, US). The FDA issued a Cleared decision on July 28, 1997 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.

FDA 510(k) Submission Details - K972528

510(k) Number K972528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1997
Decision Date July 28, 1997
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 46
Devices cleared under the same product code (FPO) and FDA review panel - the closest regulatory comparables to K972528.
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K952447 · Hill-Rom, Inc. · Nov 1995
K972528 · DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)
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