# K033222: Olympus Sterilization Trays

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Aug 2, 2004 after 304 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: 4 generations back to K844002 (1984). 6 ancestors in all.
58 later devices descend from it; 8 cite it directly.
1 of 65 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012105: Polyvac Surgical Instrument Delivery System, Symmetry Medical, Inc. (2002)

## Most influential descendants
- K152241: Medtronic Transportation/Sterilization Cassettes (2016), 29 descendants of its own
- K163600: Kit Boxes and Kit Plates (2018), 18 descendants of its own
- K180791: Straumann BLX Surgical Cassette (2018), 11 descendants of its own
- K070769: VHP 136 Tray (2007), 10 descendants of its own
- K140494: V-Pro Sterilization Tray/ Sterilization Mat (2014), 7 descendants of its own

## Indications for use
The Olympus sterilization trays are intended to be used to enclose Olympus medical devices including hand instruments, trocars, camera heads, adapter, and endoscopes to be sterilized by a health care provider. It is intended to allow steam sterilization of the enclosed medical device. The qualification for sterilizing endoscopic instruments were validated with a process challenge device (PCD) by a GLP approved laboratory. The PCD has a diameter of 2 mm and a length of 1500 mm. The Olympus sterilization trays are to be sterilized in the following cycle: Prevacuum Steam: 132°C- 134°C- 5 minutes minimum Drying Time: 10 - 20 minutes as needed.

Source page: https://510kreport.com/device/K033222
Methodology: https://510kreport.com/methodology