# K050570: Miltex Rigid Sterilization Container System

- Pathway: 510(k) (Traditional)
- Applicant: Miltex, Inc.
- Decided: Jul 25, 2005 after 143 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.
7 later devices descend from it; 2 cite it directly.
0 of 11 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.

## Most influential descendants
- 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
- K123234: Ermis Sterilization Container System (2013), 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 high vacuum steam sterilizers. The containers have been validated for sterilization of instruments with lumens up to 3 mm I.D. by 400 mm length, for the Full (large) size container and up to 3 mm I.D. by 200 mm length for the 1/2 (small) and 3/4 (medium) size containers. Sterilized devices may be stored and transported within the container.

Source page: https://510kreport.com/device/K050570
Methodology: https://510kreport.com/methodology