# K061194: Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558

- Pathway: 510(k) (Abbreviated)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Aug 24, 2006 after 118 days
- Product code: MEG (Syringe, Antistick)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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). 6 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 16 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.
- K030683: Nipro Disposable Syringes, Nipro 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 use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.

Source page: https://510kreport.com/device/K061194
Methodology: https://510kreport.com/methodology