# ECB: Unit, Syringe, Air And/Or Water

- Device class: 1; regulation: 21 CFR 872.4565; FDA's rule: 510(k) exempt
- FDA decisions: 12
- 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)
- 1978: 1
- 1980: 1
- 1986: 2
- 1989: 1
- 1991: 1
- 1992: 2
- 1993: 2
- 1994: 2

## Most-cited predicates

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