# K072563: Miltex Rigid Container Systems

- Pathway: 510(k) (Traditional)
- Applicant: Miltex, Inc.
- Decided: Feb 12, 2008 after 154 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 K871202 (1987). 5 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022978: Steritite Container with Flashtite Valve Plate (S) & Meditray Products, Case Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K102146: Bahadir Sterilization Trays (2010), 3 descendants of its own
- K112090: Bahadir Sterilization Trays (2012), 2 descendants of its own
- K092437: Codman Sterilization Containers (2010), 2 descendants of its own
- K131407: Bahadir Sterilization Trays (2014), 1 descendant of its own
- K120117: Codman Quad-Lock Sterilization Container System (2012), 1 descendant of its own

## Indications for use
The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using gravity steam sterilizers. The recommended gravity steam sterilization cycle parameters are 45 minutes exposure at 121 deg C and a 20 minute dry time. 2 metal lumens 3-mm in diameter and up to 200-mm in length were validated. The container is intended for use with non-porous materials such as stainless steel surgical instruments. For effective sterilization and drying, the weight of the single container, basket and basket contents should not exceed the following: 16 lbs for the one-half size container, 20 lbs for the three-quarter size container, and 25 lbs for the full size container. Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility for a maximum of 60 days as long as the integrity of the container has not been compromised. Containers should not be stacked when used within gravity steam sterilizers.

Source page: https://510kreport.com/device/K072563
Methodology: https://510kreport.com/methodology