# K003424: Pinnacle R/O II or Radifocus Introducer II

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Nov 21, 2000 after 18 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K082847: Pinnacle Roii Introducer Sheath (2008), 3 descendants of its own
- K132592: Flexor Radial Hydrophilic Introducer Access Set (2014), 2 descendants of its own
- K152044: Flexor Radial Hydrophilic Introducer Access Set (2015), 1 descendant of its own
- K171609: Check-Flo Performer Introducer Micropuncture Radial Artery Access Set (2018), 0 descendants of its own
- K062446: Modification to Pinnacle Roii Hiflow Introducer Sheath (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K003424
Methodology: https://510kreport.com/methodology