# FIE: Needle, Fistula

- Device class: 2; regulation: 21 CFR 876.5540; FDA's rule: 510(k) required
- FDA decisions: 80
- 510(k) review time 2021–2025: median 129 days (middle half 94–165)
- Recalls: 7 (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)
- 2010: 3
- 2011: 3
- 2012: 1
- 2014: 2
- 2015: 2
- 2017: 1
- 2018: 1
- 2022: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K932074: Medisystems Apheresis Needle with Guard (1994), cited by 4
- K990803: Medisystems Buttonhole Needle Sets (2000), cited by 4
- K955182: Nipro Arterial Venous Fistula Needle (1996), cited by 3
- K990470: JMS a. V. Fistula Needle Set (1999), cited by 3
- K854773: Supercath a.V. Fistula (1986), cited by 2
- K111948: Wingeater V2 (2011), cited by 2
- K093637: JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300 and 820-7300 (2010), cited by 1
- K142564: JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) (2014), cited by 1
- K051814: JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle Set (2005), cited by 1
- K002813: Nipro Safetouch Safety Fistula Needle (2000), cited by 1

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