# MLR: Sterilizer, Chemical

- Device class: 2; regulation: 21 CFR 880.6860; FDA's rule: 510(k) required
- FDA decisions: 47
- 510(k) review time 2021–2025: median 100 days (middle half 56–222)
- Recalls: 39 (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)
- 2016: 4
- 2017: 2
- 2018: 2
- 2019: 4
- 2021: 2
- 2022: 2
- 2023: 5
- 2024: 3
- 2025: 1
- 2026: 1

## Most-cited predicates
- K062297: VHP 136 Low Temperature Sterilization System (2007), cited by 8
- K083097: Amsco V-Pro 1 Low Temperature Sterilization System (2009), cited by 6
- K102330: Amsco V-Pro Max Low Temperature Sterilization System (2011), cited by 5
- K042116: Sterrad NX Sterilizer (2005), cited by 5
- K111377: Sterrad (R) 100NX Sterilizer Duo Cycle (2012), cited by 4
- K071385: Sterrad 100NX Sterilizer (2007), cited by 4
- K142454: STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (2015), cited by 4
- K131120: Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System (2013), cited by 3
- K212200: STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette (2021), cited by 3
- K102394: Amsco V-Pro 1 Low Temperature Sterilization System; Amsco V-Pro 1 Plus Low Temperature Sterilization System (2011), cited by 2

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