# K093309: Pro-Line CT (Basic Tray) Model MR28036101

- Pathway: 510(k) (Special)
- Applicant: Medcomp ( Medical Components)
- Decided: Nov 24, 2009 after 33 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 25 ancestors in all.
8 later devices descend from it; 2 cite it directly.
2 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053345: Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D, Medcomp (2006) Summary page 1.
- K091953: Pro-Picc, Medcomp (2009) Summary page 1.

## Most influential descendants
- K101329: Synergy CT Picc (2010), 6 descendants of its own
- K130034: Uni-Picc (2013), 2 descendants of its own
- K140270: Nexus Midline CT Catheter (2014), 1 descendant of its own
- K113622: Orion II CT CVC (2012), 1 descendant of its own
- K200263: Health Line CT Midline Catheter (2020), 0 descendants of its own

## Indications for use
The Medcomp PRO-LINETM CT Power Injectable CVC is indicated for short or long term access to the.central venous system. It is designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PRO-LINETM CT Power Injectable CVC may not exceed 300 psi.

Source page: https://510kreport.com/device/K093309
Methodology: https://510kreport.com/methodology