# K112535: Genesis Reusable Rigid Container System

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion 2200, Inc.
- Decided: Apr 27, 2012 after 239 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 K844652 (1984). 4 ancestors in all.
7 later devices descend from it; 3 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)
- K844652: C.a.S.E. Container, General Medical Co. (1984) Summary page 1.
- K983299: Allegiance Genesis Container System, Allegiance Healthcare Corp. (2000) Summary page 1.
- K012931: Genesis Sterrad Compatible Reusable Sterilization Container System, Allegiance Healthcare Corp. (2002) Summary page 1.

## Most influential descendants
- K140850: Genesis Reusable Rigid Container System (2014), 3 descendants of its own
- K142529: Genesis Reusable Rigid Container System (2015), 2 descendants of its own
- K130720: Synthes Reusable Sterilization Container System (2014), 1 descendant of its own
- K181933: DePuy Synthes Sterilization Container System (2019), 0 descendants of its own
- K162600: Jewel Precision Reusable Rigid Sterilization Container System (2016), 0 descendants of its own

## Indications for use
The Genesis Reusable Rigid 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 allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days. Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use. Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container. Data cards are used to record information regarding a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.

Source page: https://510kreport.com/device/K112535
Methodology: https://510kreport.com/methodology