# K063450: Portex Hypodermic Needle- Pro Edge Safety Device, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110

- Pathway: 510(k) (Abbreviated)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Jan 25, 2007 after 71 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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 K904198 (1990). 8 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041399: Hypodermic Needle-Pro Edge Needle Protection Device, Smiths Medical Asd, Inc. (2004) Summary page 1.
- K031453: Terumo Surguard 2 Safety Needle, Terumo Medical Corp. (2003) Summary page 1.

## Most influential descendants
- K071785: Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with Syringe (2007), 7 descendants of its own
- K211634: Hypodermic Needle-Pro EDGE Safety Device (2021), 5 descendants of its own
- K232943: Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe (2024), 4 descendants of its own
- K242291: SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle (2024), 2 descendants of its own
- K253110: Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (2026), 0 descendants of its own

## Indications for use
This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.

Source page: https://510kreport.com/device/K063450
Methodology: https://510kreport.com/methodology