# K022170: Inner-Lock Locking Introducer Sheaths

- Pathway: 510(k) (Traditional)
- Applicant: Rex Medical
- Decided: Jan 21, 2003 after 202 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: 2 generations back to K954234 (1995). 2 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954234: Radifocus Introducer II Kit, Terumo Medical Corp. (1995) Summary page 1.
- K984260: Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator), Terumo Medical Corp. (1999) Summary page 1.

## Most influential descendants
- K032569: Short Introducer Sheath (2003), 15 descendants of its own
- K033793: Cleaner II Rotational Thrombectomy System (2003), 12 descendants of its own
- K040252: Cleaner Rotational Thrombectomy System Kit (2004), 11 descendants of its own
- K060904: Cleaner Rotational Thrombectomy System (2006), 10 descendants of its own
- K091029: Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) (2010), 9 descendants of its own

## Indications for use
The Inner-Lock Locking introducer Sheaths are used to facilitate placing a catheter through the skin into a graft. The Inner-Lock 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 sheath.

Source page: https://510kreport.com/device/K022170
Methodology: https://510kreport.com/methodology