# K200126: VERIFY Assert Self-Contained Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: May 22, 2020 after 122 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173634: CELERITY 20 Steam Biological Indicator, STERIS Corporation (2018) Summary page 5.

## Indications for use
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization processes. Cycle Type Temperature Time Dynamic Air Removal 270°F (132°C) 4 minutes Dynamic Air Removal 275°F (135°C) 3 minutes Gravity 250°F (121°C) 30 minutes Gravity 270°F (132°C) 15 minutes When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes

Source page: https://510kreport.com/device/K200126
Methodology: https://510kreport.com/methodology