Cleared Traditional

K110748 - OLYMPUS INSTRUMENT TRAY

K110748 is the FDA 510(k) clearance for OLYMPUS INSTRUMENT TRAY by Olympus Winter & Ibe GmbH. It is a Class 2 General Hospital device (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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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

Submission Details

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.

Device Classification

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 160
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K110748.
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