# K140708: Verify V24 Self-Contained Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jun 16, 2014 after 87 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 K994055 (2002). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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.
- K090514: Verify Self-Contained Biological Indicator for Vaporized (VH2O2) Sterilization Processes, STERIS Corporation (2009) Summary page 2.

## Most influential descendants
- K172474: Celerity 20 HP Biological Indicator (2017), 0 descendants of its own

## Indications for use
The VERIFY 4 V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles: " Lumen, Non Lumen and Flexible Cycles of the V-PROO Low Temperature Sterilization Systems * Default Cycle of the STERRAD 1005S Sterilizer * Default Cycle of the STERRAD 200 Sterilizer * Standard and Advanced Cycles of the STERRAD NX Sterilizer " Express, Standard and Flex Scope Cycles of the STERRAD IOONX Sterilizer

Source page: https://510kreport.com/device/K140708
Methodology: https://510kreport.com/methodology