# K151017: JMS Harmony A.V. Fistula Needle Set

- Pathway: 510(k) (Special)
- Applicant: JMS North America Corporation
- Decided: May 13, 2015 after 27 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: 5 generations back to K030479 (2003). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093637: JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300 and 820-7300, Jms North America Corp. (2010) Summary page 4.
- K990470: JMS a. V. Fistula Needle Set, Jms Co., Ltd. (1999) Summary page 4.

## Indications for use
JMS Harmony® A.V.Fistula Needle Set 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 and is used on ‘developed constant site’ access sites. This device is for use on developed ‘constant site’ access sites

Source page: https://510kreport.com/device/K151017
Methodology: https://510kreport.com/methodology