# K040029: Safetynet Guidewire Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Injectimed, Inc.
- Decided: Apr 5, 2004 after 88 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 K971165 (1997). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K843719: Single Wall Introducer Needle, Ocean Medical Products, Ltd. (1984) Summary page 1.
- K851834: Manan Gwi Guide Wire Introducer, Manan Manufacturing Co., Inc. (1985) Summary page 1.
- K031173: Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013, Needle Tech Products, Inc. (2003) Summary page 1.
- K011085: Guidewire Introducer Safety Needle, Medamicus, Inc. (2001) Summary page 1.
- K020563: Medamicus Axia RSN, Medamicus, Inc. (2002) Summary page 1.
- K022689: Modification to Medamicus Axia RSN, Medamicus, Inc. (2002) Summary page 1.

## Most influential descendants
- K073664: Frontline Medical Safetynet Guidewire Introducer (2008), 0 descendants of its own

## Indications for use
The Frontline Medical Products SafetyNet TM Guidewire Introducer is intended for single use, for percutaneous introduction and placement of guidewires in vascular procedures, with provision of a feature enabling the user to shield the needle point after use to reduce the risk of accidental sharps injury.

Source page: https://510kreport.com/device/K040029
Methodology: https://510kreport.com/methodology