# K192001: Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device

- Pathway: 510(k) (Traditional)
- Applicant: Sterilucent, Inc.
- Decided: Oct 22, 2019 after 88 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: 5 generations back to K042450 (2005). 6 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K140589: Sterrad Cyclesure 24 Plus Biological Indicator, Mesa Laboratories, Inc. (2014) Summary page 4.
- K141312: Sterilucent Process Challenge Device, Sterilucent, Inc. (2014) Summary page 4.

## Most influential descendants
- 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 SCBI is intended to be used as a standard method for frequent monitoring of the Sterilucent HC 80TT Sterilizer Cycles, when incorporated into a test pack. The Sterilucent Process Challenge Device (PCD) test pack is used for routine monitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles. The Sterilucent PCD may also be used for performance qualification of the Sterilucent HC 80TT sterilizer Lumen and Flexible Cycles during initial installation, after relocation, major repairs or mal functions, or after sterilization process failures. Both the Sterilucent Lumen Cycle PCD and the Sterilucent Flexible Cycle PCD are intended to have greater resistance than the stand alone SCBI. Both devices are designed to have increased resistance beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.

Source page: https://510kreport.com/device/K192001
Methodology: https://510kreport.com/methodology