# K140499: Verify V24 Self-Contained Biological Indicator for Vaporized VH202 Sterilization Processes

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jul 17, 2014 after 140 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). 9 ancestors in all.
14 later devices descend from it; 3 cite 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)
- K073244: Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization Processes, STERIS Corporation (2008) Summary page 2.
- K103331: Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization Processes, STERIS Corporation (2011) Summary page 7.

## Most influential descendants
- 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
- K172752: CELERITY 20 HP Biological Indicator (2018), 8 descendants of its own
- K183294: CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack (2019), 6 descendants of its own
- K223717: Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack (2023), 3 descendants of its own

## Indications for use
The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the Lumen, Non Lumen and Flexible cycles of V-PRO® Low Temperature Sterilization Systems, The VERIFY V24 Biological Indicator Challenge Pack is intended for qualification testing of the Lumen. Non Lumen and Flexible Cycles in V-PRO Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Source page: https://510kreport.com/device/K140499
Methodology: https://510kreport.com/methodology