# K030502: 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: May 20, 2003 after 90 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972207 (1998). 4 ancestors in all.
13 later devices descend from it; 4 cite it directly.
3 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994105: Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40, Medical Components, Inc. (2001) Summary page 1.
- K012562: Medcomp 14.5F Double Lumen Hemodialysis Catheter, Medical Components, Inc. (2002)

## Most influential descendants
- K040992: 15F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706 (2004), 8 descendants of its own
- K070572: Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM (2007), 7 descendants of its own
- K080400: Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit (2008), 6 descendants of its own
- K140492: Nexsite HD (55CM), Hemodialysis Catheter for Long Term Use (2014), 2 descendants of its own
- K101843: Duramax Chronic Hemodialysis Catheter and Procedure Kit (2010), 2 descendants of its own

## Recalls of this device
- Feb 5, 2015 · Class II · Z-1351-2015: Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product ship
- May 19, 2011 · Not classified · Z-2693-2011: Product was packaged with the incorrect valved peelable introducer. The catheter sized is 15.5F and the introducer packaged in the kit is a 15F. The kit should contain a 16F introducer.

## Indications for use
THE MEDCOMP HEMO-FLOWTMDOUBLE LUMEN CATHETER IS INDICATED FOR USE IN ATTAINING LONG-TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARY PLACED IN THE INTERNAL JUGULAR VEIN. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.

Source page: https://510kreport.com/device/K030502
Methodology: https://510kreport.com/methodology