Cleared Traditional

K853535 - TRAUMA TABLE

K853535 is an FDA 510(k) clearance for TRAUMA TABLE, manufactured by Xre Corp.. The device is a Class 1 General & Plastic Surgery device with product code GDC cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K853535 · Xre Corp. · General & Plastic Surgery device
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Sep 1985
Decision
19d
Days
Class 1
Risk

K853535 is an FDA 510(k) clearance for the TRAUMA TABLE. Classified as Table, Operating-room, Electrical (product code GDC), Class I - General Controls.

Submitted by Xre Corp. (Littleton, US). The FDA issued a Cleared decision on September 11, 1985 after a review of 19 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 Xre Corp. devices

FDA 510(k) Submission Details - K853535

510(k) Number K853535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1985
Decision Date September 11, 1985
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
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.