Cleared Traditional

GENERAL SURGERY TRAY (K940444) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K940444 · Cush Medical Products · General & Plastic Surgery device
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Mar 1994
Decision
34d
Days
Class 1
Risk

K940444 is an FDA 510(k) clearance for the GENERAL SURGERY TRAY. Classified as Tray, Surgical (product code LRP), Class I - General Controls.

Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 Cush Medical Products devices

Submission Details

510(k) Number K940444 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received February 01, 1994
Decision Date March 07, 1994
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRP Tray, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.