Cleared Traditional

K112535 - GENESIS REUSABLE RIGID CONTAINER SYSTEM

K112535 is an FDA 510(k) clearance for GENESIS REUSABLE RIGID CONTAINER SYSTEM, manufactured by Carefusion 2200, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K112535 · Carefusion 2200, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
239d
Days
Class 2
Risk

K112535 is an FDA 510(k) clearance for the GENESIS REUSABLE RIGID CONTAINER SYSTEM. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Carefusion 2200, Inc. (Waukegan, US). The FDA issued a Cleared decision on April 27, 2012 after a review of 239 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 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 Carefusion 2200, Inc. devices

FDA 510(k) Submission Details - K112535

510(k) Number K112535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2011
Decision Date April 27, 2012
Days to Decision 239 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
110d slower than avg
Panel avg: 129d · This submission: 239d
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 173
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K112535.
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
SONICISION STERILIZATION TRAY
K112536 · Covidien · Apr 2012
CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM
K120117 · Codman & Shurtleff, Inc. · Apr 2012
OLYMPUS INSTRUMENT TRAY
K110748 · Olympus Winter & Ibe GmbH · Feb 2012