# JOJ: Indicator, Physical/Chemical Sterilization Process

- Device class: 2; regulation: 21 CFR 880.2800; FDA's rule: 510(k) required
- FDA decisions: 267
- 510(k) review time 2021–2025: median 84 days (middle half 30–139)
- Recalls: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 7
- 2018: 5
- 2019: 12
- 2020: 7
- 2021: 4
- 2022: 8
- 2023: 4
- 2024: 12
- 2025: 6
- 2026: 3

## Most-cited predicates
- K921910: Sterrad Chemical Indicator (1993), cited by 5
- K922481: Browne GA Indicator Use in 2% Activ Glutaraldehyde (1994), cited by 5
- K070461: Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4 (2007), cited by 3
- K991709: Browne Cidex Opa Indicator (1999), cited by 3
- K960441: Steritec Integraph Model CI-101 (1997), cited by 3
- K140566: Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator Tape (2014), cited by 3
- K902958: TST Control Integrator for Steam Autoclave (1990), cited by 3
- K140940: Process Indicator Tape for Steam Sterilization (2014), cited by 3
- K012195: Steam Sterilization Intergrator (2002), cited by 3
- K932129: 3M Autoclave Tapes (1994), cited by 3

Source page: https://510kreport.com/product-code/JOJ
Data by year (CSV): https://510kreport.com/product-code/JOJ.csv