# K073244: Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization Processes

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: May 28, 2008 after 191 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: 3 generations back to K994055 (2002). 3 ancestors in all.
20 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)
- K994055: Sterrad Cyclesure Biological Indicator, Advanced Sterilization Products (2002) Summary page 2.
- K031226: Sterrad Cyclesure Biological Indicator, Advanced Sterilization Products (2003) Summary page 2.
- K071014: Modification to Sterrad Cyclesure Biological Indicator, Advanced Sterilization Products (2007) Summary page 2.

## Most influential descendants
- 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
- 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

## Indications for use
The Verify Self-Contained Biological Indicator for Vaporized H₂O Sterilization Processes is intended as a standard method for frequent monitoring of the Amsco® V-PRO™ 1 Low Temperature Sterilization System.

Source page: https://510kreport.com/device/K073244
Methodology: https://510kreport.com/methodology