Cleared Traditional

STERIS CMAX XLT SURGICAL TABLE (K090136) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K090136 · STERIS Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
58d
Days
Class 1
Risk

K090136 is an FDA 510(k) clearance for the STERIS CMAX XLT SURGICAL TABLE. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on March 20, 2009 after a review of 58 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

Submission Details

510(k) Number K090136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date March 20, 2009
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.