# K090514: Verify Self-Contained Biological Indicator for Vaporized (VH2O2) Sterilization Processes

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Mar 16, 2009 after 18 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 K994055 (2002). 4 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K073244: Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization Processes, STERIS Corporation (2008) Summary page 1.
- K994055: Sterrad Cyclesure Biological Indicator, Advanced Sterilization Products (2002) Summary page 1.
- K031226: Sterrad Cyclesure Biological Indicator, Advanced Sterilization Products (2003) Summary page 1.
- K071014: Modification to Sterrad Cyclesure Biological Indicator, Advanced Sterilization Products (2007) Summary page 1.

## Most influential descendants
- K141580: Sterizone Self-Contained Biological Indicator (2014), 1 descendant of its own
- K140708: Verify V24 Self-Contained Biological Indicator (2014), 1 descendant of its own
- K203560: STERIZONE VP4 Test Pack (2021), 0 descendants of its own
- K172474: Celerity 20 HP Biological Indicator (2017), 0 descendants of its own

## Indications for use
The Verify- V24 Self-Contained Biological Indicator is intended as a standard method for frequent monitoring of the Amsco® V-PROTM 1 Low Temperature Sterilization System.

Source page: https://510kreport.com/device/K090514
Methodology: https://510kreport.com/methodology