# K051814: JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle Set

- Pathway: 510(k) (Special)
- Applicant: Jms North America Corp.
- Decided: Aug 4, 2005 after 30 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 K030479 (2003). 1 ancestor in all.
7 later devices descend from it; 1 cites 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)
- K030479: JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle Set, Jms North America Corp. (2003) Summary page 1.

## Most influential descendants
- K070234: JMS Sysloc Mini Avf and Apheresis Needle Sets (2007), 6 descendants of its own
- K110157: Sysloc Mini V3 (2011), 2 descendants of its own
- K082882: A.V. Fistula Blunt Needle Set (2009), 2 descendants of its own
- K142564: JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) (2014), 1 descendant 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

## Indications for use
Use for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device is intended for single use only and has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries.

Source page: https://510kreport.com/device/K051814
Methodology: https://510kreport.com/methodology