# K042858: 55CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated Tips

- Pathway: 510(k) (Traditional)
- Applicant: Spire Biomedical, Inc.
- Decided: Dec 3, 2004 after 49 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 48 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K013160 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032061: Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH, Spire Biomedical, Inc. (2003) Summary page 1.

## Most influential descendants
- K073092: Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, (2008), 0 descendants of its own

## Recalls of this device
- Oct 23, 2009 · Not classified · Z-0288-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0289-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0290-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0299-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0301-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0302-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0304-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0306-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0309-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0311-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0312-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0294-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0295-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0296-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0297-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0300-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0303-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0307-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0308-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0314-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0316-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0317-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0318-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0319-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0321-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0330-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0291-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0292-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0293-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0298-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0305-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0310-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0313-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0315-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0320-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0322-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0323-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0324-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0325-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0327-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0328-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0332-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0334-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0335-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0329-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0331-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0333-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi
- Oct 23, 2009 · Not classified · Z-0326-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi

## Indications for use
The 55cm 15.5Fr Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown. Catheters longer than 40cm are intended for femoral vein insertion.

Source page: https://510kreport.com/device/K042858
Methodology: https://510kreport.com/methodology