# K061033: Miltex Rigid Sterilization Container System, (47 Components)

- Pathway: 510(k) (Traditional)
- Applicant: Miltex, Inc.
- Decided: Dec 12, 2006 after 242 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: 3 generations back to K991023 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023614: Steritite Rigid Reusable Sterilization Container System, Case Medical, Inc. (2003) Summary page 1.

## 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 ethylene oxide gas sterilizers. Metal lumens 3-mm in diameter and length up to 200-mm in length were validated. The container intended for use with non-porous materials such as stainless steel surgical instruments. Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the medical devices within it until used. Containers should not be stacked when used within ethylene oxide sterilizers The device models that are the subject of this pre-market notification on listed on page 2 of this Indications for Use statement.

Source page: https://510kreport.com/device/K061033
Methodology: https://510kreport.com/methodology