# K994105: Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Oct 3, 2001 after 667 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: 1 generation back to K972207 (1998). 1 ancestor in all.
20 later devices descend from it; 6 cite it directly.
4 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972207: Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CM, Medcomp (1998) Summary page 1.

## Most influential descendants
- K030502: 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55 (2003), 13 descendants of its own
- 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
- K121933: Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis Catheter for Long Term Use (24CM) (2013), 4 descendants of its own

## Recalls of this device
- Jul 27, 2020 · Class II · Z-2940-2020: Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer
- 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

## Indications for use
The Medcomp Hemo-Flow Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site includes the subclavian vein as required.

Source page: https://510kreport.com/device/K994105
Methodology: https://510kreport.com/methodology