# K183300: VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack

- Pathway: 510(k) (Traditional)
- Applicant: Steris Corporations
- Decided: Jan 3, 2019 after 37 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: 7 generations back to K042450 (2005). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172748: VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack, Steris Corporations (2018) Summary page 6.

## Most influential descendants
- K231490: Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator (2023), 1 descendant of its own
- K252680: Celerity™ 20 HP Biological Indicator (2025), 0 descendants of its own

## Indications for use
The VERIFY V24 BI Challenge Pack is intended for qualification testing of the V PRO 1, V-PRO 1 Plus, VPRO maX, V-PRO maX 2, V-PRO 60 and V PRO s 2 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. The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles: • Lumen, Non Lumen, Flexible, Fast and Fast Non Lumen Cycles of the V-PRO® 1, 1 Plus, maX, maX 2, 60 and s 2 Sterilizers • STERRAD® 100S Sterilizer (default cycle) • STERRAD® 200 Sterilizer (default cycle) • Standard and Advanced Cycles of the STERRAD® NX Sterilizer to include sterilizers with All Clear Technology • Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizer to include sterilizers with All Clear technology

Source page: https://510kreport.com/device/K183300
Methodology: https://510kreport.com/methodology