Cleared Traditional

K940616 - SKYTRON ELITE 3500 TABLE

K940616 is an FDA 510(k) clearance for SKYTRON ELITE 3500 TABLE, manufactured by Skytron, Div. the Kmw Group, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDC cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K940616 · Skytron, Div. the Kmw Group, Inc. · General & Plastic Surgery device
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Jun 1994
Decision
119d
Days
Class 1
Risk

K940616 is an FDA 510(k) clearance for the SKYTRON ELITE 3500 TABLE. Classified as Table, Operating-room, Electrical (product code GDC), Class I - General Controls.

Submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on June 13, 1994 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4960 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Skytron, Div. the Kmw Group, Inc. devices

FDA 510(k) Submission Details - K940616

510(k) Number K940616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1994
Decision Date June 13, 1994
Days to Decision 119 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

GDC Device Classification - Class 1, General Controls

Product Code GDC Table, Operating-room, Electrical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
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.

Regulatory Peers - GDC Table, Operating-room, Electrical

All 13
Devices cleared under the same product code (GDC) and FDA review panel - the closest regulatory comparables to K940616.
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