# K124046: Valved Tearaway Introducer Generation II

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Jun 3, 2013 after 154 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K932323 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090394: Valved Tearway Introducer, Medcomp (2009) Summary page 1.

## Indications for use
The Valved Tearaway Introducers are intended to obtain central venous access to facilitate catheter insertion into the central venous system.

Source page: https://510kreport.com/device/K124046
Methodology: https://510kreport.com/methodology