# K110748: Olympus Instrument Tray

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Feb 15, 2012 after 335 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K844002 (1984). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092682: Gyrus Acmi Flexible Endoscope Storage-Sterilization Trays, Gyrus Acmi, Inc. (2009) Summary page 1.
- K033222: Olympus Sterilization Trays, Olympus Winter & Ibe GmbH (2004) Summary page 1.

## Indications for use
This instrument tray is intended to be used to enclose and protect Olympus flexible endoscopes during sterilization. The instrument tray is designed to hold one endoscope at a time and is to be used in conjunction with an FDA cleared sterilization wrap for ethylene oxide sterilization. the instrument tray is an optional accessory to the Olympus endoscopes for which it is designed. Maintenance of sterility depends on the sterilization wrap, not on the instrument tray. This instrument tray is indicated for ethylene oxide sterilization of only compatible Olympus endoscopes. For compatible endoscopes, refer to the table below, "Compatible Olympus Endoscopes".

Source page: https://510kreport.com/device/K110748
Methodology: https://510kreport.com/methodology