# K110682: Steritite Container System & Meditray Products

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical, Inc.
- Decided: Jul 1, 2011 after 113 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: 2 generations back to K040865 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080558: Steritite Container System & Meditray Products, Case Medical, Inc. (2008) Summary page 1.
- K093493: Aesculap Sterilcontainer S, Aesculap, Inc. (2010) Summary page 1.

## Most influential descendants
- K161415: SteriTite Containers System & MediTray Products (2017), 0 descendants of its own

## Indications for use
The SteriTite universal container system with MediTray products is a reusable sterilization container system intended to be used to enclose other medical devices and instrumentation to be sterilized, transported and stored by health care providers. The container consists of a perforated base and lid with filter retention plates~ and disposable polypropylene filters. The SteriTite universal container system is compatible for use with STERRAD 100NX Sterilization (Standard and Flex cycles). The SteriTite container has been validated with stainless steel and porous lumens, inoculated product, insert boxes, multilevel tray systems and various inserts including brackets, posts and partitions. The container may be used for sterilization of medical devices including full instrument sets and mixed loads. SteriTite universal container system is recommended to be used for sterilization of surfaces and lumens: - In STERRAD 100NX Standard cycle, process stainless steel lumens instruments of 0.7 mm diameter or larger and up to 500 mm in length. - In STERRAD 100NX Flexible cycle, process flexible endloscopes, PE/PTFE Lumen instruments of :1.2 mm x 835 mm. 120 days of real time Shelf life testing with handling events has been conducted for SteriTite containers after STERRAD 100NX Sterilization. Reuse testing was performed after 501 STERRAD 100NX Standard cycles.

Source page: https://510kreport.com/device/K110682
Methodology: https://510kreport.com/methodology