# K012931: Genesis Sterrad Compatible Reusable Sterilization Container System

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Aug 20, 2002 after 354 days
- Product code: FRG (Wrap, Sterilization)
- 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: 1 generation back to K991023 (2000). 1 ancestor in all.
18 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991023: Steritite Perforated Bottom Rigid Reusable Sterilization Container System with SCF02 - Polypropylene Non-Woven Disposabl, Case Medical, Inc. (2000) Summary page 1.

## Most influential descendants
- K023614: Steritite Rigid Reusable Sterilization Container System (2003), 9 descendants of its own
- K112535: Genesis Reusable Rigid Container System (2012), 7 descendants of its own
- K050570: Miltex Rigid Sterilization Container System (2005), 7 descendants of its own
- K091720: Sklarlite Rigid Sterilization Container System (2010), 6 descendants of its own
- K140850: Genesis Reusable Rigid Container System (2014), 3 descendants of its own

## Indications for use
A sterilization container system is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. This container system is intended to be used in STERRADB 50, STERRAD@ 100 and STERRADB IOOS, ethylene oxide and pre-vacuum sterilization processes.

Source page: https://510kreport.com/device/K012931
Methodology: https://510kreport.com/methodology