Cleared Traditional

K103226 - STERILIZATION MATS

K103226 is an FDA 510(k) clearance for STERILIZATION MATS, manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K103226 · STERIS Corporation · General Hospital
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Feb 2011
Decision
109d
Days
Class 2
Risk

K103226 is an FDA 510(k) clearance for the STERILIZATION MATS. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on February 18, 2011 after a review of 109 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all STERIS Corporation devices

FDA 510(k) Submission Details - K103226

510(k) Number K103226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2010
Decision Date February 18, 2011
Days to Decision 109 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 129d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 209
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K103226.
STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
K110682 · Case Medical, Inc. · Jul 2011
STAT-MAT MINOR
K110500 · Macpherson Medical, Inc. · Jun 2011
GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT
K102970 · Gyrus Acmi, Inc. · May 2011
FINESS ENDOSCOPE STERILIZATION TRAY
K103213 · Entellus Medical, Inc. · Feb 2011
SKELETAL DYNAMICS STERILIZATION TRAYS
K102103 · Skeletal Dynamics, LLC · Dec 2010
SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428
K102122 · Smith & Nephew, Inc. · Nov 2010