Cleared Traditional

K110682 - STERITITE CONTAINER SYSTEM & MEDITRAY P...

K110682 is an FDA 510(k) clearance for STERITITE CONTAINER SYSTEM & MEDITRAY P..., manufactured by Case Medical, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K110682 · Case Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
113d
Days
Class 2
Risk

K110682 is an FDA 510(k) clearance for the STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Case Medical, Inc. (South Hackensack, US). The FDA issued a Cleared decision on July 1, 2011 after a review of 113 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 Case Medical, Inc. devices

FDA 510(k) Submission Details - K110682

510(k) Number K110682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2011
Decision Date July 01, 2011
Days to Decision 113 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
16d faster than avg
Panel avg: 129d · This submission: 113d
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 K110682.
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K110748 · Olympus Winter & Ibe GmbH · Feb 2012
GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT
K102970 · Gyrus Acmi, Inc. · May 2011
STERILIZATION MATS
K103226 · STERIS Corporation · Feb 2011
FINESS ENDOSCOPE STERILIZATION TRAY
K103213 · Entellus Medical, Inc. · Feb 2011