# FLE: Sterilizer, Steam

- Device class: 2; regulation: 21 CFR 880.6880; FDA's rule: 510(k) required
- FDA decisions: 185
- 510(k) review time 2021–2025: median 136 days (middle half 93–212)
- Recalls: 13 (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: 3
- 2018: 8
- 2019: 5
- 2020: 2
- 2021: 5
- 2022: 10
- 2023: 7
- 2024: 2
- 2025: 4
- 2026: 3

## Most-cited predicates
- K792558: Container System (1979), cited by 7
- K990189: Modification of: Midmark M-11 Ultraclave Steam Sterilizer (1999), cited by 5
- K082435: Amsco Evolution Medium Steam Sterilizer (2008), cited by 4
- K111736: Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves (2011), cited by 4
- K012573: Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and 533HC (2001), cited by 4
- K023348: Midmark M9 Ultraclave Steam Sterilizer (2003), cited by 4
- K033538: Belimed Steam Sterilizer Top 5000, Series 4 - 8 (2004), cited by 3
- K143311: Pre-vacuum Tabletop Autoclave (2015), cited by 3
- K183410: AMSCO 600 Steam Sterilizer (2019), cited by 3
- K003470: Ehs Series Table Top Autoclave, Models 2540 and 3870 (2001), cited by 3

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