# K163025: DORA Disposable A.V. Fistula Needle Sets

- Pathway: 510(k) (Traditional)
- Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.
- Decided: Jul 20, 2017 after 262 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). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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.

## Most influential descendants
- K213015: DORA Disposable A.V. Fistula Needle Sets (2022), 0 descendants of its own

## Indications for use
The DORA 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. The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment.

Source page: https://510kreport.com/device/K163025
Methodology: https://510kreport.com/methodology