Cleared Traditional

K962181 - HARE MODEL 2000 EZ LOADER MODEL 95555

K962181 is an FDA 510(k) clearance for HARE MODEL 2000 EZ LOADER MODEL 95555, 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 56-day FDA review.

K962181 · Dyna Corp. · General Hospital
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Aug 1996
Decision
56d
Days
Class 2
Risk

K962181 is an FDA 510(k) clearance for the HARE MODEL 2000 EZ LOADER MODEL 95555. Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by Dyna Corp. (Carlsbad, US). The FDA issued a Cleared decision on August 1, 1996 after a review of 56 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 - K962181

510(k) Number K962181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1996
Decision Date August 01, 1996
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
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 K962181.
DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)
K972528 · Dyna Corp. · Jul 1997
WHEELED STRETCHER
K961437 · Hill-Rom, Inc. · Jun 1996
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