# K051468: Inner-Lock Introducer Sheath

- Pathway: 510(k) (Special)
- Applicant: Rex Medical
- Decided: Aug 4, 2005 after 62 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 K954234 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022170: Inner-Lock Locking Introducer Sheaths, Rex Medical (2003) Summary page 1.
- K042399: Modification to Short Introducer Sheath, Rex Medical, L.P. (2004) Summary page 1.

## Indications for use
The Inner-Lock Introducer Sheath is used to facilitate placing a catheter through the skin into a graft. The dilator is an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling system.

Source page: https://510kreport.com/device/K051468
Methodology: https://510kreport.com/methodology