# K210866: Steri-Dot Process Indicator

- Pathway: 510(k) (Abbreviated)
- Applicant: Propper Manufacturing Co., Inc.
- Decided: Jun 21, 2021 after 90 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: 1 generation back to K002861 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002861: EO Gas Sterilization Process Indicator Tapes, Model CI 124, Steritec Products, Inc. (2000) Summary page 5.

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

## Indications for use
The Steri-Dot Process Indicator for EO gas sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed units or loads. The indicator dots turn from purple-red to green when exposed to EO gas sterilization conditions, thus providing an indication of processed items. The Steri-Dot process indicator can be used in the following EO sterilization cycles: 1. 37°C, 736 mg/l EO, >35% RH, 3 hours exposure 2. 37°C, 759 mg/l EO, >35% RH, 3 hours exposure 3. 54°C, 600 mg/l EO, 40-60% RH, 45 min or longer exposure 4. 54°C, 736 mg/l EO, >35% RH, 1 hour exposure 5. 55°C, 759 mg/l EO, >35% RH, 1 hour exposure 6. 55°C, 600 mg/l EO, 40-60% RH, 4 hours exposure

Source page: https://510kreport.com/device/K210866
Methodology: https://510kreport.com/methodology