# K173634: CELERITY 20 Steam Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Feb 12, 2018 after 80 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: 3 generations back to K926364 (1995). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121484: 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader, 3M Company (2012) Summary page 5.

## Most influential descendants
- K200126: VERIFY Assert Self-Contained Biological Indicator (2020), 0 descendants of its own
- K181686: CELERITY 20 Steam Biological Indicator (2018), 0 descendants of its own

## Indications for use
The Celerity 20 Steam Biological Indicator is used for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization cycles: 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 Celerity™ Steam Incubator, the Incubator provides a fluorescent result within 20 minutes.

Source page: https://510kreport.com/device/K173634
Methodology: https://510kreport.com/methodology