Cleared Abbreviated

K112536 - SONICISION STERILIZATION TRAY

K112536 is an FDA 510(k) clearance for SONICISION STERILIZATION TRAY, manufactured by Covidien. The device is a Class 2 General Hospital device with product code KCT cleared through the Abbreviated 510(k) pathway after a 231-day FDA review.

K112536 · Covidien · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
231d
Days
Class 2
Risk

K112536 is an FDA 510(k) clearance for the SONICISION STERILIZATION TRAY. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on April 19, 2012 after a review of 231 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Covidien devices

FDA 510(k) Submission Details - K112536

510(k) Number K112536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2011
Decision Date April 19, 2012
Days to Decision 231 days
Submission Type Abbreviated
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
102d slower than avg
Panel avg: 129d · This submission: 231d
Pathway characteristics
Standards-based clearance path.

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 191
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K112536.
THS INSTRUMENT TRAY
K120947 · Hologic, Inc. · Oct 2012
TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS
K112087 · Advanced Sterilization Products · Oct 2012
GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY
K120474 · Gyrus Acmi, Inc. · Jul 2012
CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM
K120117 · Codman & Shurtleff, Inc. · Apr 2012
OLYMPUS INSTRUMENT TRAY
K110748 · Olympus Winter & Ibe GmbH · Feb 2012
GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT
K102970 · Gyrus Acmi, Inc. · May 2011