# K162945: VERIFY ASSERT STEAM Process Challenge Device

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Apr 28, 2017 after 189 days
- Product code: OWP (Biological Sterilization Process Indicator With Recombinant-Dna Plasmid)
- Device class: 2
- Regulation: 21 CFR 880.2805
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The VERIFY™ Assert™ STEAM Process Challenge Device (PCD) is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers. The validated steam sterilization cycles include: • 270°F (132°C) 4-minute dynamic air removal • 275°F (135°C) 3-minute dynamic air removal

Source page: https://510kreport.com/device/K162945
Methodology: https://510kreport.com/methodology