# MIB: Elastomer, Silicone Block

- Device class: 2; regulation: 21 CFR 874.3620; FDA's rule: 510(k) required
- FDA decisions: 45
- 510(k) review time 2021–2025: median 102 days (middle half 90–127)
- Recalls: 3 (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)
- 2003: 2
- 2004: 2
- 2005: 3
- 2017: 1
- 2018: 1
- 2019: 1
- 2020: 1
- 2022: 3
- 2023: 1
- 2024: 1

## Most-cited predicates
- K181387: Pre-Formed Penile Silicone Block (2019), cited by 3
- K022223: Aart Silicone Sheeting (2002), cited by 2
- K021820: Aart Silicone Carving Block (2002), cited by 2
- K162624: Pre-Formed Penile Silicone Block (2017), cited by 2
- K171851: Softxil (2018), cited by 2
- K042380: Silicone Block (2004), cited by 2
- K022511: Aart Calf Implant (2002), cited by 1
- K052504: Gluteal Implant, Models RND 5-X, TRD 6-X (2005), cited by 1
- K193392: BioSiCar Silicone Implant (2020), cited by 1
- K982688: Spectrum Designs Pre-Form Contour Silicone Carving Block (1998), cited by 1

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