# QBP: Cap, Device Disinfectant

- Device class: 2; regulation: 21 CFR 880.5440; FDA's rule: 510(k) required
- FDA decisions: 22
- 510(k) review time 2021–2025: median 463 days (middle half 463–463)
- Recalls: 0 (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)
- 2009: 1
- 2010: 1
- 2011: 2
- 2012: 4
- 2013: 2
- 2014: 2
- 2015: 1
- 2020: 4
- 2024: 1
- 2026: 2

## Most-cited predicates
- K083508: Swabcap (2009), cited by 6
- K080466: Alcohol Pad (2008), cited by 5
- K093229: Catheter Connections Dualcap (2010), cited by 5
- K111992: Curos Port Protector (2012), cited by 5
- K130975: Swabcap and Swabflush (2013), cited by 2
- K080579: Effectiv (TM) Cap (2008), cited by 2
- K110826: Curos Port Protector (2011), cited by 1
- K142806: DualCap (2015), cited by 1
- K113842: Catheter Connections' Dualcap Solo (2012), cited by 1
- K123065: Catheter Connections Dualcap Solo (2012), cited by 1

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