Cleared Traditional

U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER (K922816) - FDA 510(k) Clearance

Class I General Hospital device.

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

Submission Details

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.

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.