# K121848: Split Cath Iii 24CM Split Cath Iii 24CM Split Cath Iii 32CM Cath Iii 36CM Split Cath Iii 40CM and 55CM

- Pathway: 510(k) (Special)
- Applicant: Medical Components, Inc.
- Decided: Sep 21, 2012 after 88 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K123292: T3 (2013), 2 descendants of its own
- K183219: Trio-CT Triple Lumen Catheter (2019), 1 descendant of its own
- K232945: Trio-CT­® Triple Lumen Catheter w/ Curved Extensions (2023), 0 descendants of its own
- K130889: Split Cath RG (2014), 0 descendants of its own

## Recalls of this device
- Aug 4, 2014 · Class II · Z-2592-2014: The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.

## Indications for use
The Medcomp@ Split Oath® Ill is indicated for use in attaining long term vascular access for Hernodialysis and Apheresis in the adult patient. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and inferior vena cava as required. Catheters greater than 40cm are intended for femoral vein or inferior vena cava insertion. The Medcornp® Split Oath® IIl isindicated for use in attaining long term vascular access for Hemodialysis and Apheresis in the adult patent. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Aldternate insertion sites include the subclavian vein and inferior vena cava as required. Catheters greater than 40cm are intended for femoral vein or inferior vena cava insertion. Translumbar insertion via inferior vena cave isindicated when all other access sites are identified as non-viable.

Source page: https://510kreport.com/device/K121848
Methodology: https://510kreport.com/methodology