# K954234: Radifocus Introducer II Kit

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Nov 27, 1995 after 77 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
No predicates in its family tree.
93 later devices descend from it; 5 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K033681: Glidesheath (2003), 43 descendants of its own
- K062858: Modification to Glidesheath (2006), 42 descendants of its own
- K082644: Glidesheath (2008), 41 descendants of its own
- K052557: Super Sheath Introducer Sheath (2006), 30 descendants of its own
- K984260: Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator) (1999), 23 descendants of its own

Source page: https://510kreport.com/device/K954234
Methodology: https://510kreport.com/methodology