Cleared Traditional

K853480 - SKYTRON ELITE 6000 & 6001 SURGICAL TABLES

K853480 is an FDA 510(k) clearance for SKYTRON ELITE 6000 & 6001 SURGICAL TABLES, 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 23-day FDA review.

K853480 · Skytron, Div. the Kmw Group, Inc. · General & Plastic Surgery device
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Sep 1985
Decision
23d
Days
Class 1
Risk

K853480 is an FDA 510(k) clearance for the SKYTRON ELITE 6000 & 6001 SURGICAL TABLES. 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 September 12, 1985 after a review of 23 days - a notably fast clearance cycle.

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: 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 Skytron, Div. the Kmw Group, Inc. devices

FDA 510(k) Submission Details - K853480

510(k) Number K853480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1985
Decision Date September 12, 1985
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
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 K853480.
MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE
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MOBILE OPERATING TABLE FOR ORL MICROSURGERY
K853720 · Carl Zeiss, Inc. · Oct 1985
TRAUMA TABLE
K853535 · Xre Corp. · Sep 1985
MAYFIELD TABLE-ELECTRIC
K851021 · Ohio Medical Instrument Co., Inc. · May 1985
SKYTRON ELITE 3100 SURGICAL TABLE
K851829 · Skytron, Div. the Kmw Group, Inc. · May 1985