Cleared Traditional

K140494 - V-PRO STERILIZATION TRAY/ STERILIZATION...

K140494 is the FDA 510(k) clearance for V-PRO STERILIZATION TRAY/ STERILIZATION... by STERIS Corporation. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K140494 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
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

Submission Details

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.

Device Classification

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 145
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K140494.
SterilContainer S
K143729 · Aesculap, Inc. · Aug 2015
SterilContainer S System
K142970 · Aesculap, Inc. · Jul 2015
Endoscope Sterilization Tray
K142937 · Intuitive Surgical, Inc. · Feb 2015
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