# FLF: Sterilizer, Ethylene-Oxide Gas

- Device class: 2; regulation: 21 CFR 880.6860; FDA's rule: 510(k) required
- FDA decisions: 26
- Recalls: 6 (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)
- 1990: 1
- 1991: 2
- 1993: 2
- 1994: 4
- 2003: 3
- 2006: 1
- 2009: 1
- 2015: 2
- 2017: 1
- 2020: 1

## Most-cited predicates
- K820783: Castle Microcomputer Sterilizer Control (1982), cited by 3
- K150646: EOGas 4 Ethylene Oxide Gas Sterilizer (2015), cited by 2
- K020875: TSO3 Ozone Sterilizer, Model 125L (2003), cited by 2
- K090636: TSO3 Ozone Sterilizer, Model 125L (2009), cited by 1
- K051595: TSO3 Ozone Sterilizer, Model 125L (2006), cited by 1
- K812867: Steri-Vac #400C Gas Sterilizer (1981), cited by 1
- K901146: Joslyn EO Sterilizer/ EO Modernization Kit (1991), cited by 1
- K941748: Steri-Vac Gas Sterilizer Model 8XL (1994), cited by 1
- K873200: Karlson Ozone Sterilizer Model 100B (1989), cited by 1
- K023290: Sterrad 50 & Sterrad 100S Sterilizers (2003), cited by 1

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