Cleared Traditional

FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-W (K924669) - FDA 510(k) Clearance

Class I General Hospital device.

K924669 · Ferno · General Hospital
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Apr 1993
Decision
225d
Days
Class 1
Risk

K924669 is an FDA 510(k) clearance for the FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-W. Classified as Stretcher, Hand-carried (product code FPP), Class I - General Controls.

Submitted by Ferno (Wilmington, US). The FDA issued a Cleared decision on April 29, 1993 after a review of 225 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ferno devices

Submission Details

510(k) Number K924669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1992
Decision Date April 29, 1993
Days to Decision 225 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
96d slower than avg
Panel avg: 129d · This submission: 225d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.