# K092682: Gyrus Acmi Flexible Endoscope Storage-Sterilization Trays

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Dec 11, 2009 after 101 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: 5 generations back to K844002 (1984). 10 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040223: Polyvac Instrument Delivery System, Symmetry Medical USA, Inc. (2004) Summary page 1.
- K033222: Olympus Sterilization Trays, Olympus Winter & Ibe GmbH (2004) Summary page 1.

## Most influential descendants
- K122818: Olympus Maj-172 Instrument Tray for LTF Videoscope (2013), 1 descendant of its own
- K133116: Video Extended Length Tray (Plastic - Radel), Video Tray Single Level (Plastic - Radel), Video Arthroscope Tray (Plastic (2014), 0 descendants of its own
- K120474: Gyrus Acmi Telescope Storage-Sterilization Tray (2012), 0 descendants of its own
- K110748: Olympus Instrument Tray (2012), 0 descendants of its own
- K102970: Gyrus Acmi Cyber Wand-Sterilization Trays Model FGT (2011), 0 descendants of its own

## Indications for use
The Gyrus ACMI® Flexible Endoscope Storage-Sterilization Trays are intended to be used to enclose and protect Gyrus ACMI flexible endoscopes during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the Gyrus ACMI endoscopes for which they are designed. Maintenance of sterility depends on the sterilization wrap, not the tray. The trays are indicated for ETO sterilization of only the following Gyrus ACMI Flexible Endoscopes ICN ICN-0564, ICN-0565 DUR-D DUR-D, DUR-DBA ACN ACN-2T7, ACN-2TBA DUR-8 DUR-S, DUR-8-BA, DUR-8E, DUR-8E-BA, DUR-8 Ultra AUR AUR-7, AUR-735 EtO Sterilization parameters: EtO Sterilize using 100% ethylene oxide Temp: 55°C, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 725-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration: 12 hours @55°C

Source page: https://510kreport.com/device/K092682
Methodology: https://510kreport.com/methodology