# K111948: Wingeater V2

- Pathway: 510(k) (Special)
- Applicant: JMS North America Corporation
- Decided: Oct 24, 2011 after 108 days
- Product code: FIE (Needle, Fistula)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010406 (2001). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010406: JMS a.V. Fistula Needle Set Wing Eater, Model 14G-18G, Jms Co., Ltd. (2001) Summary page 1.

## Most influential descendants
- K251877: JMS CAVEO A.V. Fistula Needle Set (2025), 0 descendants of its own
- K131950: Angel Tip Safety Intravascular Needle Set (2015), 0 descendants of its own

## Indications for use
Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and .WingEater guard) aids in prevention of needlestick injuries when removing and discarding needle after dialysis session.

Source page: https://510kreport.com/device/K111948
Methodology: https://510kreport.com/methodology