# K171505: Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)

- Pathway: 510(k) (Traditional)
- Applicant: Dimesol, Inc.
- Decided: May 17, 2018 after 359 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: 2 generations back to K932074 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071145: Nipro Safetouch Tulip Safety Fistula Needle, Nipro Medical Corporation (2007) Summary page 6.
- K990470: JMS a. V. Fistula Needle Set, Jms Co., Ltd. (1999) Summary page 6.
- K013037: Excel a.V Fisutal Needle Set, Exelint Intl. Co. (2001) Summary page 6.

## Indications for use
The Dimesol Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. This device is for in-hospital or hemodialysis center use only. The Dimesol Disposable A.V. Fistula Needle Sets (Safety Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield aids in the prevention of accidental needlesticks. This device is for in- hospital or hemodialysis center use only.

Source page: https://510kreport.com/device/K171505
Methodology: https://510kreport.com/methodology