# K202721: Celerity 20 Steam Biological Indicator for IUSS

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jan 8, 2021 after 113 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: 2 generations back to K900771 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103277: 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader, 3M Company-3M Health Care (2011) Summary page 5.

## Indications for use
The Celerity 20 STEAM Biological Indicator for IUSS is used for monitoring and qualification testing of the following steam sterilization cycles: Gravity 270°F (132°C) 3 minutes Gravity 270°F (132°C) 10 minutes Gravity 275°F (135°C) 3 minutes Gravity 275°F (135°C) 10 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/K202721
Methodology: https://510kreport.com/methodology