# K082882: A.V. Fistula Blunt Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Jms North America Corp.
- Decided: Jan 21, 2009 after 113 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: 3 generations back to K030479 (2003). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990803: Medisystems Buttonhole Needle Sets, Medisystems Corp. (2000) Summary page 1.
- K010406: JMS a.V. Fistula Needle Set Wing Eater, Model 14G-18G, Jms Co., Ltd. (2001) Summary page 2.
- K070234: JMS Sysloc Mini Avf and Apheresis Needle Sets, Jms North America Corp. (2007) Summary page 1.

## Most influential descendants
- 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
- K151017: JMS Harmony A.V. Fistula Needle Set (2015), 0 descendants of its own

## Indications for use
The JMS Blunt AV Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment The device is intended for single use only The JMS AV Fistula Blunt Needle Set is for use on developed 'constant site' access sites

Source page: https://510kreport.com/device/K082882
Methodology: https://510kreport.com/methodology