# KYZ: Syringe, Irrigating (Non Dental)

- Device class: 1; regulation: 21 CFR 880.6960; FDA's rule: 510(k) exempt
- FDA decisions: 41
- Recalls: 12 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1994: 2
- 1995: 2
- 1996: 2
- 1997: 1
- 1998: 2
- 1999: 1
- 2005: 1
- 2009: 1
- 2011: 1
- 2020: 1

## Most-cited predicates
- K050797: Tissu-Trans (2005), cited by 6
- K881020: Surgical Sealant Dispenser (SSD) (1988), cited by 3
- K883338: Surgical Sealant Applicator (1988), cited by 2
- K884749: Johnson & Johnson Sterile Spray Tip Syringe (1988), cited by 1
- K102563: Single Cannula Extended Applicator (2011), cited by 1
- K964833: Rmi Dual Fluid Irrigating Syringe (1997), cited by 1

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