# K030135: Safety Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jul 15, 2003 after 182 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: 3 generations back to K801941 (1980). 7 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011085: Guidewire Introducer Safety Needle, Medamicus, Inc. (2001)
- K021094: Introcan Safety IV Catheter, B.Braun Medical, Inc. (2002)

## Most influential descendants
- K050023: Secureloc; Advancintroducer (2005), 5 descendants of its own
- K142445: Pinpoint GT Safety Introducer Needle (2015), 1 descendant of its own
- K070449: Lumiloc (TM) Safety Introducer Needle (2007), 1 descendant of its own
- K180725: Aspire Introducer Needle (2018), 0 descendants of its own
- K162769: Pinpoint GT Introducer Needle (2016), 0 descendants of its own

## Indications for use
The Safety Introducer Needle incorporates an active safety clip mechanism designed to minimize inadvertent needlesticks when the needle is used to introduce a guidewire.

Source page: https://510kreport.com/device/K030135
Methodology: https://510kreport.com/methodology