# MAV: Syringe, Balloon Inflation

- Device class: 2; regulation: 21 CFR 870.1650; FDA's rule: 510(k) required
- FDA decisions: 58
- 510(k) review time 2021–2025: median 28 days (middle half 28–28)
- Recalls: 22 (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)
- 2006: 1
- 2008: 1
- 2011: 1
- 2012: 4
- 2013: 1
- 2014: 2
- 2015: 3
- 2016: 3
- 2022: 1
- 2026: 1

## Most-cited predicates
- K955869: Scimed Encore 26 Inflation Device/Encore 30 Inflation Device (1996), cited by 3
- K953522: Usci Ideal Ptca Kit (1996), cited by 2
- K082755: Sedat Flamingo (2008), cited by 2
- K942269: Medtronic Everest Inflation Device (1994), cited by 2
- K120694: Encore 26 Advantage Kit (2012), cited by 2
- K040138: Viceroy Inflation Device (2004), cited by 2
- K993341: Intellisystem II Color Monitor (1999), cited by 2
- K123214: Encore 26 Advantage Kit (2012), cited by 2
- K130566: Basixtouch (2013), cited by 2
- K042449: Dolphin Inflation Device (2005), cited by 2

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