# K032292: Bioteque a.V. Fistula Needle Set with Safety Flex

- Pathway: 510(k) (Traditional)
- Applicant: Bioteque Corp.
- Decided: Mar 22, 2004 after 242 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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 K010406 (2001). 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)
- K010406: JMS a.V. Fistula Needle Set Wing Eater, Model 14G-18G, Jms Co., Ltd. (2001) Summary page 1.

## Indications for use
The BIOTEQ Arterial-Venous Fistula (A.V.F.) Needle Set with Safety Flex is used for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The Safety Feature (Safety Flex) aids in prevention of needle-sticks injuries when removing and discarding needles after dialysis session.

Source page: https://510kreport.com/device/K032292
Methodology: https://510kreport.com/methodology