# K023162: Fresenius Punctur-Guard Fistula Needle Sets

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care
- Decided: Mar 20, 2003 after 178 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 K003827 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003827: Punctur-Guard Winged Set for Blood Collection, Bio-Plexus, Inc. (2001) Summary page 1.
- K010406: JMS a.V. Fistula Needle Set Wing Eater, Model 14G-18G, Jms Co., Ltd. (2001)

## Indications for use
The Fresenius PUNCTUR-GUARD@Fistula Needle Set is indicated for use as a non-implantable (less than 30 days use) vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit. The set includes a needlestick prevention device using PUNC7UR-GUARD@technology. The features of this device may aid in the prevention of needlestick injury. This device is intended for single use only.

Source page: https://510kreport.com/device/K023162
Methodology: https://510kreport.com/methodology