# K182724: CelerityTM 10 STEAM Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Dec 10, 2018 after 73 days
- Product code: JOJ (Indicator, Physical/Chemical 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 K960441 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070461: Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4, STERIS Corporation (2007) Summary page 5.

## Indications for use
The Celerity 10 STEAM Chemical Indicator is intended for use in dynamic air removal steam sterilization cycles operating at 270°F/132°C for 10 minutes. The Celerity 10 STEAM Chemical Indicator is a Type 6 indicator that changes colors from yellow to blue/purple when exposed to these cycle conditions.

Source page: https://510kreport.com/device/K182724
Methodology: https://510kreport.com/methodology