# K974236: Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon XL Soft-Line Double Lumen Catheter, 20CM SB

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Apr 15, 1999 after 519 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- 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
No predicates in its family tree.
24 later devices descend from it; 4 cite it directly.
2 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K991320: Medcomp Duo-Flow II Catheter with Lubricious Heparin (1999), 16 descendants of its own
- K060509: Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating (2006), 7 descendants of its own
- K062671: 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire) (2006), 6 descendants of its own
- K023914: Coaxia Flocontrol Catheter (2003), 6 descendants of its own
- K112477: Palindrome H, SI, Hsi Chronic Catheter (2011), 5 descendants of its own

## Indications for use
The Medcomp Duo-Flow and Duo-Fiow 400 XL Double Lumen Catheters are designed for acute hemodialysis and apheresis. They may be inserted percutaneously and are ideally placed in the internal jugular vein. Although these catheters may be inserted into the subclavian or femoral vein, the internal jugular is the preferred site.

Source page: https://510kreport.com/device/K974236
Methodology: https://510kreport.com/methodology