# K134019: Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle Protector, Medisystems Onesite Dual Lumen Butto

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Sep 11, 2014 after 255 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 K823068 (1983). 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)
- K990803: Medisystems Buttonhole Needle Sets, Medisystems Corp. (2000) Summary page 5.
- K801355: Bionics BI-Flo Stretch (Double Lumen for, Cordis Corp. (1980) Summary page 5.

## Indications for use
The Medisystems Dual Lumen Needle is indicated for use as a vascular access device for dialysis procedures. The Medisystems Dual Lumen Buttonhole Needle is indicated for use as a vascular access device for dialysis procedures using a constant-site or “buttonhole” method of needle insertion.

Source page: https://510kreport.com/device/K134019
Methodology: https://510kreport.com/methodology