# K990470: JMS a. V. Fistula Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Jms Co., Ltd.
- Decided: Aug 30, 1999 after 195 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
No predicates in its family tree.
3 later devices descend from it; 3 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K171505: Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) (2018), 0 descendants of its own
- K151017: JMS Harmony A.V. Fistula Needle Set (2015), 0 descendants of its own
- K112734: Aplan a.V. Fistula Needle Set (2012), 0 descendants of its own

## Indications for use
Use for temporary cannulation fcr vascular access for extracorporeal blood treatment. This device is intended to single use only and is for temporary catheterization less than 30 days. Regarding to pre-attached Anti-stick device, use for prevention of needlestick injury at the time of needle withdrawal after usage.

Source page: https://510kreport.com/device/K990470
Methodology: https://510kreport.com/methodology