# NZW: Heparin, Vascular Access Flush

- Device class: 2; regulation: 21 CFR 880.5200; FDA's rule: 510(k) required
- FDA decisions: 7
- Recalls: 27 (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)
- 2003: 1
- 2007: 1
- 2009: 1
- 2010: 2
- 2014: 1
- 2017: 1

## Most-cited predicates
- K023740: Syrex Pre-Filled Syringe (2003), cited by 3
- K061497: Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/ML (2007), cited by 1
- K090680: Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe (2009), cited by 1

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