Cleared Traditional

K920890 - OPERATING TABLE SYSTEM-BETAMAQUET 1140

K920890 is an FDA 510(k) clearance for OPERATING TABLE SYSTEM-BETAMAQUET 1140, manufactured by Stierlen-Maquet AG. The device is a Class 1 General & Plastic Surgery device with product code FQO cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K920890 · Stierlen-Maquet AG · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
141d
Days
Class 1
Risk

K920890 is an FDA 510(k) clearance for the OPERATING TABLE SYSTEM-BETAMAQUET 1140. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by Stierlen-Maquet AG (West Germany, GR). The FDA issued a Cleared decision on July 2, 1992 after a review of 141 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.

FDA 510(k) Submission Details - K920890

510(k) Number K920890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1992
Decision Date July 02, 1992
Days to Decision 141 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 115d · This submission: 141d
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 34
Devices cleared under the same product code (FQO) and FDA review panel - the closest regulatory comparables to K920890.
FISK HEADREST
K924700 · Rhino Mfg. · Jan 1993
DRAGER DVE 4000 SERIES SYSTEM
K921297 · Alm Surgical Equipment, Inc. · Nov 1992
PNEUMO-WEDGE
K921143 · Kansas Creative Devices, Inc. · Sep 1992
SPINAL POSITIONING FRAME
K922371 · Rhino Mfg. · Jun 1992
TELETOM(R)
K921626 · Berchtold Holding GmbH · May 1992
712 PLASTIC SURGERY TABLE & ACCESORIES
K915141 · Midmark Corp. · Jan 1992
K920890 · OPERATING TABLE SYSTEM-BETAMAQUET 1140
Download PDF FDA Summary Stierlen-Maquet AG