# K210553: Steam-Dot Process Indicator

- Pathway: 510(k) (Abbreviated)
- Applicant: Propper Manufacturing Co., Inc.
- Decided: May 19, 2021 after 83 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 K001649 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140940: Process Indicator Tape for Steam Sterilization, Canadian Technical Tape, Ltd. (2014) Summary page 7.

## Most influential descendants
- K241036: Autoclave Indicator Tape; EO Indicator Tape (2024), 0 descendants of its own

## Indications for use
The Steam-Dot Process Indicator for steam sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed and unprocessed units or loads. The indicator dots turn from white to dark brown/black when exposed to steam sterilization conditions, thus providing an indication of processed items. The Steam-Dot process indicator can be used in the following steam sterilization cycles: *Gravity: 121 C/250 F - 30 minutes *Vacuum assisted (pre-vacuum): 132 C/270 F - 3 minutes *Vacuum assisted (pre-vacuum): 132 C/270 F - 4 minutes *Vacuum assisted (pre-vacuum): 134 C/273 F - 3 minutes *Vacuum assisted (pre-vacuum): 134 C/273 F - 4 minutes *Vacuum assisted (pre-vacuum): 135 C/275 F - 3 minutes

Source page: https://510kreport.com/device/K210553
Methodology: https://510kreport.com/methodology