# K863138: Terumo Radifocus Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Nov 20, 1986 after 97 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
36 later devices descend from it; 12 cite it directly.
1 of 37 devices in its family (counting itself) has 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
- K092303: Merit Laureate Hydrophilic Guide Wire (2009), 9 descendants of its own
- K152740: Radifocus Glidewire (2015), 8 descendants of its own
- K120644: Merit Hydrophilic Guide Wire (2012), 8 descendants of its own
- K063372: Radifocus Glidewire Advantage (2007), 7 descendants of its own
- K130588: Merit Hydrophilic Guide Wire (2013), 6 descendants of its own

Source page: https://510kreport.com/device/K863138
Methodology: https://510kreport.com/methodology