# K112734: Aplan a.V. Fistula Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Aplan Well Enterprise Co., Ltd.
- Decided: Apr 24, 2012 after 217 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: 1 generation back to K990470 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990470: JMS a. V. Fistula Needle Set, Jms Co., Ltd. (1999) Summary page 1.

## Indications for use
The A. V. Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device is intended for single use only

Source page: https://510kreport.com/device/K112734
Methodology: https://510kreport.com/methodology