# MOL: Condom, Synthetic

- Device class: 2; regulation: 21 CFR 884.5300; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 244 days (middle half 132–268)
- 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)
- 2008: 2
- 2011: 1
- 2016: 1
- 2017: 2
- 2018: 1
- 2022: 1
- 2023: 1
- 2024: 3
- 2025: 2
- 2026: 1

## Most-cited predicates
- K160399: Skyn Original Polyisoprene Lubricated Male Condom (2016), cited by 3
- K100767: Trojan Supra Lubricated Polyurethane Male Condom (2011), cited by 2
- K962816: Sperm Preparation Media (1996), cited by 1
- K203541: Okamoto 002 Lubricated Polyurethane Male Condom (2022), cited by 1
- K171172: Skyn Original Polyisoprene Lubricated Male Condom - Flavored (2017), cited by 1
- K050828: Trojan Supra Lubricated Polyurethane Male Condom (2006), cited by 1
- K942697: Trojan Polyurethane Condom (1995), cited by 1
- K070800: Lifestyles Lubricated Polyisoprene Latex Male Condom (2008), cited by 1
- K171639: Trojan Supra Lubricated Polyurethane Male Condom (2017), cited by 1

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