# K030479: JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Jms North America Corp.
- Decided: Aug 18, 2003 after 186 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; 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051814: JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle Set (2005), 7 descendants of its own
- 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

## Indications for use
Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The device has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries when withdrawing and discarding the needle after treatment.

Source page: https://510kreport.com/device/K030479
Methodology: https://510kreport.com/methodology