# MED: Sterilant, Medical Devices

- Device class: 2; regulation: 21 CFR 880.6885; FDA's rule: 510(k) required
- FDA decisions: 65
- 510(k) review time 2021–2025: median 29 days (middle half 26–62)
- Recalls: 10 (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)
- 2013: 1
- 2014: 1
- 2016: 1
- 2017: 1
- 2018: 2
- 2019: 4
- 2021: 2
- 2022: 1
- 2023: 2
- 2026: 2

## Most-cited predicates
- K875280: Steris System 1 Processor and 20 Sterilant (1988), cited by 5
- K090036: System 1.5 Sterile Processing System (2010), cited by 4
- K101409: System IE Liquid Chemical Cterilant Processing System (2010), cited by 3
- K932740: Homepump NSF (1993), cited by 3
- K211607: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate (2021), cited by 3
- K915170: Pymah Cold Sterilog Glutaraldehyde Monitor (1992), cited by 3
- K070627: Opaciden Solution (2007), cited by 3
- K924334: Cidex Formula 7* Long-Life Activated Dialdehyde (1994), cited by 3
- K030004: 0.55% Orth-Phthalaldehyde Solution (2003), cited by 3
- K970230: Sporox (1997), cited by 3

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