# K142109: Sterilucent Sterilization Container System

- Pathway: 510(k) (Traditional)
- Applicant: Sterilucent, Inc.
- Decided: Jan 20, 2015 after 169 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 K844652 (1984). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112535: Genesis Reusable Rigid Container System, Carefusion 2200, Inc. (2012) Summary page 8.

## Indications for use
The Sterilucent 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 the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen Cycles. The sterility maintenance period has been validated for a period of up to 180 days. Reusable baskets and accessory items (clips, posts, pins, dividers, brackets, bars and mats) are intended to organize and secure enclosed medical devices during sterilization, transport, and storage of the container. Consumable accessory items (filter media, data card and tamper evident arrows) provide a range of functions and are indicated as single-use devices. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Data cards are used to record information regarding a specific sterilization process load. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains an external process indicator that serves as a visual indication that the system has been exposed to the Sterilucent VHP sterilization process.

Source page: https://510kreport.com/device/K142109
Methodology: https://510kreport.com/methodology