Cleared Traditional

K090136 - STERIS CMAX XLT SURGICAL TABLE

K090136 is an FDA 510(k) clearance for STERIS CMAX XLT SURGICAL TABLE, manufactured by STERIS Corporation. The device is a Class 1 General & Plastic Surgery device with product code FQO cleared through the Traditional 510(k) pathway after a 58-day FDA review.

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

FDA 510(k) Submission Details - K090136

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
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 17
Devices cleared under the same product code (FQO) and FDA review panel - the closest regulatory comparables to K090136.
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