# HIS: Condom

- Device class: 2; regulation: 21 CFR 884.5300; FDA's rule: 510(k) required
- FDA decisions: 402
- 510(k) review time 2021–2025: median 129 days (middle half 90–236)
- Recalls: 4 (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: 5
- 2017: 4
- 2018: 2
- 2019: 1
- 2020: 4
- 2021: 5
- 2022: 10
- 2023: 2
- 2025: 5
- 2026: 2

## Most-cited predicates
- K955648: K-Y Personal Lubricant (1996), cited by 15
- K032124: Durex Play Lubricant (2004), cited by 7
- K980319: Durex Ultra Comfort (1998), cited by 5
- K912901: Trojan (TM-TBD) Condom (1992), cited by 4
- K942858: Latex Condoms W/Spermicidal Lubricant (Nonoxynol-9) (1995), cited by 4
- K900679: Mint Scented Condoms (1990), cited by 3
- K001212: Trojan Extra Large Latex Condom (2000), cited by 3
- K131887: Trojan Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (2013), cited by 3
- K033076: Lifestyles Liquid Personal Lubricant (2003), cited by 3
- K073016: Trojan Thintensity Brand Male Latex Condom Lubricated with Ultrasmooth and Warm Sensations Lubricant (2007), cited by 3

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