# K142529: Genesis Reusable Rigid Container System

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion 2200, Inc.
- Decided: Jan 8, 2015 after 121 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K844652 (1984). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140850: Genesis Reusable Rigid Container System, Carefusion 2200, Inc. (2014) Summary page 10.

## Most influential descendants
- K162600: Jewel Precision Reusable Rigid Sterilization Container System (2016), 0 descendants of its own
- K153554: Genesis Low Temperature Reusable Rigid Container System (2016), 0 descendants of its own

## Recalls of this device
- Jan 30, 2023 · Class II · Z-1236-2023: Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.
- Sep 26, 2022 · Class II · Z-0203-2023: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

## 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 health care provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed medical 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/K142529
Methodology: https://510kreport.com/methodology