# K112256: Steris Steam PI

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Jan 11, 2012 after 159 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: 4 generations back to K932129 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060103: Albert Browne LTD. Verify Steam Value Indicators, Albert Browne, Ltd. (2006) Summary page 2.

## Indications for use
The STERIS TEA 7r is a process indicator that undergoes a visual color change from a pink to brown color when exposed to the following steam sterilization cycle parameters: * 121°C (250°F), 30 min, steam sterilization gravity cycle * 132°C (270°F), 15 min, steam sterilization gravity cycle * 135°C (275°F), 10 min, steam sterilization gravity cycle * 132°C (270°F), 4 min, steam sterilization dynamic air removal cycle * 135°C (275°F), 3 min, steam sterilization dynamic air removal cycle

Source page: https://510kreport.com/device/K112256
Methodology: https://510kreport.com/methodology