# K213015: DORA Disposable A.V. Fistula Needle Sets

- Pathway: 510(k) (Traditional)
- Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.
- Decided: Apr 8, 2022 after 200 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: 3 generations back to K932074 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163025: DORA Disposable A.V. Fistula Needle Sets, Bain Medical Equipment (Guangzhou) Co., Ltd. (2017) Summary page 6.

## 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 is used for protecting from needlestick injury. The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. The DORA Disposable A.V. Fistula Needle Sets (Dull Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Scab Remover is used for remove the scab at puncture position.

Source page: https://510kreport.com/device/K213015
Methodology: https://510kreport.com/methodology