Cleared Traditional

MDT SHAMPAINE 5100B AND 5100E SURGICAL TABLES (K941150) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K941150 · Mdt Technology For Life · General & Plastic Surgery device
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Jun 1994
Decision
92d
Days
Class 1
Risk

K941150 is an FDA 510(k) clearance for the MDT SHAMPAINE 5100B AND 5100E SURGICAL TABLES. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by Mdt Technology For Life (Rochester, US). The FDA issued a Cleared decision on June 10, 1994 after a review of 92 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 Mdt Technology For Life devices

Submission Details

510(k) Number K941150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1994
Decision Date June 10, 1994
Days to Decision 92 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FQO Table, Operating-room, Ac-powered
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.