# K170070: VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Apr 28, 2017 after 109 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: 4 generations back to K926364 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121593: 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super Rapid 5 Steam-Plus Challenge Pack, 3M Company (2013) Summary page 5.

## Most influential descendants
- K173629: CELERITY 20 Steam Process Challenge Device for Gravity Cycles (2018), 0 descendants of its own

## Indications for use
The VERIFY™ ASSERT™ STEAM Process Challenge Device for Gravity Cycles is used for qualification, routine microbial monitoring, and cycle monitoring of steam sterilizers. The validated steam sterilization cycles include: • 250°F (121°C) 30-minute gravity • 270°F (132°C) 15-minute gravity The VERIFY Assert Self-Contained Indicator within the Process challenge device must be used with the VERIFY Incubator for Assert Self Contained Biological Indicators. When used in conjunction with the VERIFY Incubator for Assert Self Contained Biological Indicators, the VERIFY Assert Self-Contained Indicator within the Process challenge device provides a fluorescent result within 40 minutes.

Source page: https://510kreport.com/device/K170070
Methodology: https://510kreport.com/methodology