Cleared Traditional

K924669 - FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-W

K924669 is an FDA 510(k) clearance for FERNO-WASHINGTON BASKET STRETCHER, manufactured by Ferno. The device is a Class 1 General Hospital device with product code FPP cleared through the Traditional 510(k) pathway after a 225-day FDA review.

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

FDA 510(k) Submission Details - K924669

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.

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.