# K103331: Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization Processes

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Sep 1, 2011 after 293 days
- Product code: JOJ (Indicator, Physical/Chemical 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 K042450 (2005). 4 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092906: Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization, STERIS Corporation (2009) Summary page 3.

## 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 Biological Indicator Challenge Pack for Vaporized H20 Sterilization Processes is intended for qualification testing of the Amsco® V-PRO™ 1 (cleared under K073618), Amsco V-PRO 1 Plus (Lumen and Non Lumen Cycles, K092906), and Amsco V-PRO maX (Lumen, Non Lumen and Flexible Cycles) 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 V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers. The Verify Biological Indicator Challenge Pack for Vaporized H120 Sterilization Processes is intended for qualification testing of the following cycles: Amsco V-PRO 1 Cycle Amsco V-PRO 1 Plus Lumen Cycle — sterilant/injection 2.1; 4 injections; exposure time 32 min Amsco V-PRO maX Lumen Cycle Amsco V-PRO 1 Plus Non Lumen Cycle — sterilant/injection 2.1; 4 injections; exposure time 12 min Amsco V-PRO maX Non Lumen Cycle Amsco V-PRO maX Flexible Cycle — sterilant/injection 2.1; 4 injections; exposure time 12 min

Source page: https://510kreport.com/device/K103331
Methodology: https://510kreport.com/methodology