Cleared Traditional

K930493 - QUANTUM 3080 SURGICAL TABLE

K930493 is an FDA 510(k) clearance for QUANTUM 3080 SURGICAL TABLE, manufactured by American Sterilizer Co.. 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.

K930493 · American Sterilizer Co. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 1993
Decision
141d
Days
Class 1
Risk

K930493 is an FDA 510(k) clearance for the QUANTUM 3080 SURGICAL TABLE. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on June 22, 1993 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.

View all American Sterilizer Co. devices

FDA 510(k) Submission Details - K930493

510(k) Number K930493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1993
Decision Date June 22, 1993
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 7
Devices cleared under the same product code (FQO) and FDA review panel - the closest regulatory comparables to K930493.
STERIS CMAX XLT SURGICAL TABLE
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AMSCO SURGICAL TABLE
K971307 · STERIS Corporation · Jun 1997
RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES
K926463 · Midmark Corp. · Oct 1994
712 PLASTIC SURGERY TABLE & ACCESORIES
K915141 · Midmark Corp. · Jan 1992
GENERAL SURGICAL TABLE AND ACCESSORIES
K882660 · American Sterilizer Co. · Jul 1988