Cleared Traditional

K140494 - V-PRO STERILIZATION TRAY/ STERILIZATION MAT

K140494 is an FDA 510(k) clearance for V-PRO STERILIZATION TRAY/ STERILIZATION MAT, 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 148-day FDA review.

K140494 · STERIS Corporation · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2014
Decision
148d
Days
Class 2
Risk

K140494 is an FDA 510(k) clearance for the V-PRO STERILIZATION TRAY/ STERILIZATION MAT. 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 July 25, 2014 after a review of 148 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 - K140494

510(k) Number K140494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2014
Decision Date July 25, 2014
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
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 181
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K140494.
STERILIZATION CASSETTE
K141616 · Oticon Medical AB · Sep 2014
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
K130720 · Synthes USA Products, LLC · Aug 2014
ENDOSCOPE STERILIZATION TRAY
K133942 · Intuitive Surgical · Aug 2014
VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC
K133116 · Conmed Corporation · Mar 2014
DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343
K123175 · Conmed Corporation · Feb 2013
MYOSURE INTRUMENT TRAY
K121280 · Hologic, Inc. · Feb 2013