# K142564: JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)

- Pathway: 510(k) (Special)
- Applicant: JMS North America Corporation
- Decided: Dec 23, 2014 after 103 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). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110157: Sysloc Mini V3, JMS North America Corporation (2011) Summary page 4.

## Most influential descendants
- K253469: Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) (2026), 0 descendants of its own

## Indications for use
Use for temporary cannulation non-implantable, less than 30 days) to vascular access for extra corporeal 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/K142564
Methodology: https://510kreport.com/methodology