Cleared Traditional

K130532 - IDRIVE ULTRA STERILIZATION TRAY

K130532 is an FDA 510(k) clearance for IDRIVE ULTRA STERILIZATION TRAY, manufactured by Covidien, Formerly US Surgical A Divison of Tyco H. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K130532 · Covidien, Formerly US Surgical A Divison of Tyco H · General Hospital
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Optimized for regulatory review, auditing and printing
May 2013
Decision
90d
Days
Class 2
Risk

K130532 is an FDA 510(k) clearance for the IDRIVE ULTRA STERILIZATION TRAY. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Covidien, Formerly US Surgical A Divison of Tyco H (North Haven, US). The FDA issued a Cleared decision on May 30, 2013 after a review of 90 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 Covidien, Formerly US Surgical A Divison of Tyco H devices

FDA 510(k) Submission Details - K130532

510(k) Number K130532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2013
Decision Date May 30, 2013
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
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 K130532.
ENDOSCOPE STERILIZATION TRAY
K133942 · Intuitive Surgical · Aug 2014
V-PRO STERILIZATION TRAY/ STERILIZATION MAT
K140494 · STERIS Corporation · Jul 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
THS INSTRUMENT TRAY
K120947 · Hologic, Inc. · Oct 2012