Cleared Traditional

K941150 - MDT SHAMPAINE 5100B AND 5100E SURGICAL TABLES

K941150 is an FDA 510(k) clearance for MDT SHAMPAINE 5100B AND 5100E SURGICAL ..., manufactured by Mdt Technology For Life. The device is a Class 1 General & Plastic Surgery device with product code FQO cleared through the Traditional 510(k) pathway after a 92-day FDA review.

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

FDA 510(k) Submission Details - K941150

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.

FQO Device Classification - Class 1, General Controls

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.

Regulatory Peers - FQO Table, Operating-room, Ac-powered

All 18
Devices cleared under the same product code (FQO) and FDA review panel - the closest regulatory comparables to K941150.
SKYTRON SKYBOOM SERIES
K950192 · Skytron, Div. the Kmw Group, Inc. · Apr 1995
RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES
K926463 · Midmark Corp. · Oct 1994
IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE
K942486 · Mdt Corp., Inc. · Aug 1994
ENDEX ENDOSCOPIC POSITIONING SYSTEM
K936308 · Andronic Devices, Ltd. · Mar 1994
QUANTUM 3080 SURGICAL TABLE
K930493 · American Sterilizer Co. · Jun 1993
712 PLASTIC SURGERY TABLE & ACCESORIES
K915141 · Midmark Corp. · Jan 1992