# K112178: JMS Apheresis Needle Set Wingeater (R) V2

- Pathway: 510(k) (Special)
- Applicant: JMS North America Corporation
- Decided: Oct 27, 2011 after 91 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 K010410 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010410: JMS Apheresis Needle Wing Eater, Model 14G-18G, Jms Co., Ltd. (2001) Summary page 3.

## Indications for use
Use for providing access to a donor's blood for apheresis. This device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and WingEater) aids in prevention of needlestick injuries when removing and discarding needle after blood collection.

Source page: https://510kreport.com/device/K112178
Methodology: https://510kreport.com/methodology