# K171504: VERIFY Assert VH2O2 Self-Contained Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Aug 22, 2017 after 91 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K042450 (2005). 10 ancestors in all.
9 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)
- K140499: Verify V24 Self-Contained Biological Indicator for Vaporized VH202 Sterilization Processes, STERIS Corporation (2014) Summary page 5.

## Most influential descendants
- 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
- K223717: Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack (2023), 3 descendants of its own
- K250044: Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (2025), 1 descendant of its own
- K231490: Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator (2023), 1 descendant of its own

## Recalls of this device
- May 25, 2022 · Class III · Z-1793-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
The VERIFY Assert VH2O2 Self-Contained Biological Indicator is used for routine monitoring, and qualification of Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX, and 60 Low Temperature Sterilizers in healthcare facilities. When used in conjunction with the VERIFY Incubator for Assert VH2O2 SCBI, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 20 minutes.

Source page: https://510kreport.com/device/K171504
Methodology: https://510kreport.com/methodology