# K050023: Secureloc; Advancintroducer

- Pathway: 510(k) (Traditional)
- Applicant: Specialized Health Products, Inc.
- Decided: Feb 18, 2005 after 44 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: 4 generations back to K801941 (1980). 8 ancestors in all.
5 later devices descend from it; 3 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)
- K030135: Safety Introducer Needle, B.Braun Medical, Inc. (2003) Summary page 1.
- (no number) Majestik Angiographic Introducer Needles: named in the summary without a submission number

## Most influential descendants
- 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
- K140513: Merit Safety Introducer Needle (2014), 0 descendants of its own

## Indications for use
SecureLocTM Safety Introducer Needles are intended to be used for those patients requiring percutaneous entry procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures. The SecureLocTM Safety Introducer Needles are intended to be used as integral safety-needle devices for those patients requiring percutaneous procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures. The SecureLocTM Safety Introducer Needle's safety engineered integral safety guard is advanced by the clinician. The safety guard automatically senses the end of the needle and reduces the risk of accidental needlestick injuries by locking a safety guard over the needle tip. The safety guard can be activated over stylettes, obturators, and guidewires. Will be marketed as bulk non-sterile single use devices to procedural kit manufacturers and also as sterile, non-pyrogenic, single use devices to clinical end-users. May be used in any appropriate patient population. AdvanclntroducerTM Introducer Needles are intended to be used with those patients requiring percutaneous entry procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures. Will be marketed as bulk non-sterile single use devices to procedural kit manufacturers and also as sterile, non-pyrogenic, single use devices to clinical end-users. May be used in any appropriate patient population.

Source page: https://510kreport.com/device/K050023
Methodology: https://510kreport.com/methodology