# K023614: Steritite Rigid Reusable Sterilization Container System

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical, Inc.
- Decided: Apr 7, 2003 after 161 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
Longest line of descent: 2 generations back to K991023 (2000). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012931: Genesis Sterrad Compatible Reusable Sterilization Container System, Allegiance Healthcare Corp. (2002)

## Most influential descendants
- K050570: Miltex Rigid Sterilization Container System (2005), 7 descendants of its own
- K091720: Sklarlite Rigid Sterilization Container System (2010), 6 descendants of its own
- K102146: Bahadir Sterilization Trays (2010), 3 descendants of its own
- K112090: Bahadir Sterilization Trays (2012), 2 descendants of its own
- K131407: Bahadir Sterilization Trays (2014), 1 descendant 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 container system and MediTray product is intended to be used to contain medical devices for sterilization, storage, transportation and aseptic presentation of contents in health care facilities. This includes sterilization of surfaces and lumened dev in EO, Metal lumens 2.2mm diameter or larger and length up to 45.7 cm and porous (silicone) lumened devices 3 mrn diameter or larger and length up to 40 cm were validated. The SteriTite container is designed to maintain sterility of the contents until it is used

Source page: https://510kreport.com/device/K023614
Methodology: https://510kreport.com/methodology