# K981125: Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Feb 26, 1999 after 336 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.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K113487: Hemo-Cath 10F, Hemo-Cath 12.5F (2012), 3 descendants of its own
- K123292: T3 (2013), 2 descendants of its own
- K183219: Trio-CT Triple Lumen Catheter (2019), 1 descendant of its own
- K130851: Cascade Hemodialysis/Apheresis Catheter (2014), 1 descendant of its own
- K241581: Hemodialysis Catheter (2025), 0 descendants of its own

## Recalls of this device
- Feb 23, 2018 · Class II · Z-1121-2018: There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.

Source page: https://510kreport.com/device/K981125
Methodology: https://510kreport.com/methodology