# K070449: Lumiloc (TM) Safety Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Specialized Health Products International, Inc.
- Decided: Jun 14, 2007 after 119 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K801941 (1980). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050023: Secureloc; Advancintroducer, Specialized Health Products, Inc. (2005) Summary page 1.
- K043258: Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02, Teleflex Medical (2004) Summary page 2.

## Most influential descendants
- K180725: Aspire Introducer Needle (2018), 0 descendants of its own

## Indications for use
The LumiLocTM Safety Introducer Needle is intended to be used for percutaneous procedures utilizing a sheathed introducer trocar/needle for guidewire introduction during percutaneous gastrointestinal procedures. The LumiLocTM Safety Introducer Needle's engineered integral safety guard is passively activated by the clinician upon removal of the trocar/needle from the introducer sheath. The LumiLocTM Safety Introducer Needle helps to reduce the risk of accidental trocar/needlestick injuries by locking a safety guard over the trocar/needle tip.

Source page: https://510kreport.com/device/K070449
Methodology: https://510kreport.com/methodology