# K141238: Sterilucent Self-Contained Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Sterilucent, Inc.
- Decided: Nov 3, 2014 after 174 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K994055 (2002). 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)
- K102884: Sterrad Cyclesure 24 Biological Indicator, Advanced Sterilization Products (2011) Summary page 5.
- K122362: Smart-Well Incubator, Mesa Laboratories, Inc. (2013) Summary page 5.

## Indications for use
The Sterilucent Self-Contained Biological Indicator is for monitoring the efficacy of the hydrogen peroxide sterilization process in the Sterilucent PSD-85 Sterilizer Lumen and Non-Lumen cycles. It is intended for use solely in a test pack. The Sterilucent Biological Indicator Monitoring System is intended for incubating and monitoring of the Sterilucent Self-Contained Biological Indicator.

Source page: https://510kreport.com/device/K141238
Methodology: https://510kreport.com/methodology