# K141312: Sterilucent Process Challenge Device

- Pathway: 510(k) (Traditional)
- Applicant: Sterilucent, Inc.
- Decided: Oct 31, 2014 after 164 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 K042450 (2005). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092906: Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization, STERIS Corporation (2009) Summary page 5.

## Most influential descendants
- K192001: Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device (2019), 2 descendants of its own
- K233814: 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader  (490); 3M™ Attest™ Auto-reader  (490H); 3M™ Attest™ Mini Auto-reader  (490M) (2024), 1 descendant of its own
- K241542: 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) (2024), 0 descendants of its own

## Indications for use
The Sterilucent Process Challenge Device PCD-L for Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 sterilizer during initial installation, after relocation, major repairs or malfunctions, or after sterilization process failures. The Sterilucent PCD-L may also be used for routine monitoring of the PSD-85 Sterilizer Lumen Cycle. The Sterilucent Process Challenge Device PCD-NL for Non-Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 Sterilizer during initial installation, after relocation, major repairs or malfunctions, or after sterilization process failures. The Sterilucent PCD-NL may also be used for routine monitoring of the PSD-85 Sterilizer Non-Lumen Cycle.

Source page: https://510kreport.com/device/K141312
Methodology: https://510kreport.com/methodology