Cleared Traditional

K971390 - QUANTUM 3080SP SURGICAL TABLE

K971390 is an FDA 510(k) clearance for QUANTUM 3080SP SURGICAL TABLE, manufactured by STERIS Corporation. The device is a Class 1 General & Plastic Surgery device with product code GDC cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K971390 · STERIS Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
31d
Days
Class 1
Risk

K971390 is an FDA 510(k) clearance for the QUANTUM 3080SP SURGICAL TABLE. Classified as Table, Operating-room, Electrical (product code GDC), Class I - General Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on May 15, 1997 after a review of 31 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all STERIS Corporation devices

FDA 510(k) Submission Details - K971390

510(k) Number K971390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1997
Decision Date May 15, 1997
Days to Decision 31 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
84d faster than avg
Panel avg: 115d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

GDC Device Classification - Class 1, General Controls

Product Code GDC Table, Operating-room, Electrical
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 - GDC Table, Operating-room, Electrical

All 13
Devices cleared under the same product code (GDC) and FDA review panel - the closest regulatory comparables to K971390.
MOBILE OPERATING TABLE 1132.01
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K915393 · Mdt Corp., Inc. · Dec 1991