# K073618: Verify Sirius Biological Indicator Challenge Pack

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jan 7, 2009 after 378 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: 2 generations back to K042450 (2005). 2 ancestors in all.
21 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051643: Sterrad Sterilizer Cyclesure Test Pack, Advanced Sterilization Products (2005) Summary page 2.

## Most influential descendants
- K092906: Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization (2009), 20 descendants of its own
- K103331: Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization Processes (2011), 15 descendants of its own
- K140499: Verify V24 Self-Contained Biological Indicator for Vaporized VH202 Sterilization Processes (2014), 14 descendants of its own
- K171504: VERIFY Assert VH2O2 Self-Contained Biological Indicator (2017), 9 descendants of its own
- K173488: CELERITY 20 HP Challenge Pack (2018), 8 descendants of its own

## Indications for use
The Verify Biological Indicator Challenge Pack for Vaporized H2O2 Sterilization Processes is intended for qualification testing of the Amsco V-PRO 1 Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty V-PRO 1 Sterilizer chamber; a hospital-defined challenge load is not included. The challenge pack is not intended for routine monitoring of the V-PRO 1 Sterilizer. It has been tested and validated solely for use in periodic testing of the V-PRO 1 Sterilizer.

Source page: https://510kreport.com/device/K073618
Methodology: https://510kreport.com/methodology