Cleared Traditional

K110748 - OLYMPUS INSTRUMENT TRAY

K110748 is an FDA 510(k) clearance for OLYMPUS INSTRUMENT TRAY, manufactured by Olympus Winter & Ibe GmbH. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K110748 · Olympus Winter & Ibe GmbH · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2012
Decision
335d
Days
Class 2
Risk

K110748 is an FDA 510(k) clearance for the OLYMPUS INSTRUMENT TRAY. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Olympus Winter & Ibe GmbH (Center Valley, US). The FDA issued a Cleared decision on February 15, 2012 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Olympus Winter & Ibe GmbH devices

FDA 510(k) Submission Details - K110748

510(k) Number K110748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2011
Decision Date February 15, 2012
Days to Decision 335 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
206d slower than avg
Panel avg: 129d · This submission: 335d
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 227
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K110748.
GENESIS REUSABLE RIGID CONTAINER SYSTEM
K112535 · Carefusion 2200, Inc. · Apr 2012
SONICISION STERILIZATION TRAY
K112536 · Covidien · Apr 2012
CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM
K120117 · Codman & Shurtleff, Inc. · Apr 2012
STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
K110682 · Case Medical, Inc. · Jul 2011
STAT-MAT MINOR
K110500 · Macpherson Medical, Inc. · Jun 2011
GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT
K102970 · Gyrus Acmi, Inc. · May 2011