# K010406: JMS a.V. Fistula Needle Set Wing Eater, Model 14G-18G

- Pathway: 510(k) (Traditional)
- Applicant: Jms Co., Ltd.
- Decided: Jun 20, 2001 after 128 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K111948: Wingeater V2 (2011), 2 descendants of its own
- K082882: A.V. Fistula Blunt Needle Set (2009), 2 descendants of its own
- K093637: JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300 and 820-7300 (2010), 1 descendant of its own
- K251877: JMS CAVEO A.V. Fistula Needle Set (2025), 0 descendants of its own
- K151017: JMS Harmony A.V. Fistula Needle Set (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K010406
Methodology: https://510kreport.com/methodology