# K011085: Guidewire Introducer Safety Needle

- Pathway: 510(k) (Traditional)
- Applicant: Medamicus, Inc.
- Decided: Jul 9, 2001 after 90 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.
13 later devices descend from it; 4 cite it directly.
0 of 14 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
- K030135: Safety Introducer Needle (2003), 7 descendants of its own
- K050023: Secureloc; Advancintroducer (2005), 5 descendants of its own
- K020563: Medamicus Axia RSN (2002), 3 descendants of its own
- K022689: Modification to Medamicus Axia RSN (2002), 2 descendants of its own
- K142445: Pinpoint GT Safety Introducer Needle (2015), 1 descendant of its own

Source page: https://510kreport.com/device/K011085
Methodology: https://510kreport.com/methodology