# K111453: Steam Dot Blu Process Indicator

- Pathway: 510(k) (Abbreviated)
- Applicant: Propper Mfg. Co., Inc.
- Decided: Apr 5, 2012 after 316 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Propper Steam DotTr Indicator: named in the summary without a submission number

## Indications for use
Steam Dot Blu® Process Indicator is a chemical sterilization indicator intended to be used by a health care provider with sterilization wraps, containers, cassettes, pouches or other packaging materials to distinguish between processed and unprocessed units. The indicator changes color from blue to pink when exposed to steam sterilization conditions at 121 °C in gravity displacement and 132 °C, 134 °C and 135 °C in pre-vacuum Cycles. The performance of the Steam Dot-Blu® Process Indicator meets the requirements of ANSIIAAMTJISO 11140-1:2005 for process (Class 1) indicators. No lead or heavy metals or their compounds are added in the production of the indicator.

Source page: https://510kreport.com/device/K111453
Methodology: https://510kreport.com/methodology