# K093637: JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300 and 820-7300

- Pathway: 510(k) (Traditional)
- Applicant: Jms North America Corp.
- Decided: Feb 9, 2010 after 77 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: 4 generations back to K030479 (2003). 8 ancestors in all.
1 later device descends 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)
- K082882: A.V. Fistula Blunt Needle Set, Jms North America Corp. (2009) Summary page 1.

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

## Indications for use
The JMS Blunt AV Fistula Needle Set with Site Preparation Tool is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment and for the removal of scabs that have developed over the constant site prior to cannulation.. 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/K093637
Methodology: https://510kreport.com/methodology