Cleared Traditional

K922816 - U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER

K922816 is an FDA 510(k) clearance for U P CUSTOM DESIGN, manufactured by Up Custom Design, Inc.. The device is a Class 1 General Hospital device with product code FPP cleared through the Traditional 510(k) pathway after a 397-day FDA review.

K922816 · Up Custom Design, Inc. · General Hospital
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Jul 1993
Decision
397d
Days
Class 1
Risk

K922816 is an FDA 510(k) clearance for the U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER. Classified as Stretcher, Hand-carried (product code FPP), Class I - General Controls.

Submitted by Up Custom Design, Inc. (Menominee, US). The FDA issued a Cleared decision on July 13, 1993 after a review of 397 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Up Custom Design, Inc. devices

FDA 510(k) Submission Details - K922816

510(k) Number K922816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1992
Decision Date July 13, 1993
Days to Decision 397 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 129d · This submission: 397d
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.