Cleared Traditional

K926525 - BETASTAR 1131.02 MOBILE OPERATING TABLE

K926525 is an FDA 510(k) clearance for BETASTAR 1131.02 MOBILE OPERATING TABLE, 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 286-day FDA review.

K926525 · Stierlen-Maquet AG · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
286d
Days
Class 1
Risk

K926525 is an FDA 510(k) clearance for the BETASTAR 1131.02 MOBILE OPERATING TABLE. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by Stierlen-Maquet AG (West-Germany, DE). The FDA issued a Cleared decision on October 12, 1993 after a review of 286 days - an extended review 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: 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 Stierlen-Maquet AG devices

FDA 510(k) Submission Details - K926525

510(k) Number K926525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1992
Decision Date October 12, 1993
Days to Decision 286 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
171d slower than avg
Panel avg: 115d · This submission: 286d
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 K926525.
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
GENERAL SURGICAL TABLE AND ACCESSORIES
K882660 · American Sterilizer Co. · Jul 1988