# K090068: Steritite Universal Container System and Meditray Products

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical, Inc.
- Decided: Feb 24, 2010 after 411 days
- Product code: FRG (Wrap, Sterilization)
- 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: 1 generation back to K080558 (2008). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 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.

## Most influential descendants
- K112904: Steritec Containers System & Meditray Products (2012), 1 descendant of its own
- K161415: SteriTite Containers System & MediTray Products (2017), 0 descendants of its own

## Indications for use
The Sterilite universal container system with MediTray products is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The Sterilite container system is intended for use in Steris Amsco V-PRO 1 low temperature Sterilization System Lumen Cycle. SteriTite Sealed Container system is recommended for surface and stainless steel lumens (process up to 20 stainless steel lumnened instruments of 3mm diameter or largdr and a length up to 400 mm or shorter).

Source page: https://510kreport.com/device/K090068
Methodology: https://510kreport.com/methodology