# K080558: Steritite Container System & Meditray Products

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical, Inc.
- Decided: Dec 5, 2008 after 281 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Case Medical's previously cleared SteriTite container system: named in the summary without a submission number
- (no number) Aesculap Sterilcontainer: named in the summary without a submission number
- (no number) Aesculap One Tray: named in the summary without a submission number

## Most influential descendants
- K093493: Aesculap Sterilcontainer S (2010), 4 descendants of its own
- K090068: Steritite Universal Container System and Meditray Products (2010), 2 descendants of its own
- K112904: Steritec Containers System & Meditray Products (2012), 1 descendant of its own
- K110682: Steritite Container System & Meditray Products (2011), 1 descendant of its own
- K182032: SterilContainer S System (2018), 0 descendants of its own

## Recalls of this device
- Oct 3, 2013 · Class III · Z-0434-2014: Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle 

## Indications for use
The SteriTite 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 SteriTite container system is intended for use in STERRAD 200, STERRAD NX and Ozone 125L sterilizers, as well as the sealed containers are intended for pre- vacuum steam flash sterilization (270°F for 4 minutes). The container may be used for sterilization of medical devices including full instrument sets and mixed loads. SteriTite Sealed Container system is recommended for surface and lumens: -In STERRAD® 200 Sterilization, process only stainless steel lumened instruments of 3mm diameter or larger and a length up to 400 mm. -In STERRAD NX standard cycle, process stainless steel lumened instruments of 2mm diameter or larger and up to 400 mm in length. -In STERRAD NX advanced cycle, process stainless steel lumened instruments of 1mm diameter or larger and up to 500 mm in length and porous lumens (flexible endoscope) of 1mm diameter or larger and up to 850 mm in length. -In -Pre-vacuum Steam Flash Sterilization, process stainless steel lumened instruments of 2mm diameter or larger and a length of up to 400 mm as well as porous lumens of 3mm diameter or larger and a length up to 400 mm. -In Ozone 125L Sterilization, process stainless steel lumened instruments of 3mm diameter or larger and a length up to 470 mm. The attached tables identify which products with disposable filter may be sterilized in the respective sterilization cycles.

Source page: https://510kreport.com/device/K080558
Methodology: https://510kreport.com/methodology