# K041399: Hypodermic Needle-Pro Edge Needle Protection Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Jul 28, 2004 after 63 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904198 (1990). 3 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923127: Needle-Pro Cartridge, Concord/Portex (1993) Summary page 2.
- K951254: Safetyglide Needle, Bd Becton Dickinson Vacutainer Systems Preanalytic (1995)

## Most influential descendants
- K061194: Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558 (2006), 9 descendants of its own
- K063450: Portex Hypodermic Needle- Pro Edge Safety Device, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 (2007), 8 descendants of its own
- 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

## Recalls of this device
- Feb 11, 2019 · Class II · Z-1733-2019: Incorrect needle length and gage.
- Nov 21, 2014 · Class II · Z-0897-2015: Needle is not captured in the needle safety sheath in specific lots.
- Nov 21, 2014 · Class II · Z-0898-2015: Needle is not captured in the needle safety sheath in specific lots.
- Nov 21, 2014 · Class II · Z-0899-2015: Needle is not captured in the needle safety sheath in specific lots.

## Indications for use
This device is intended for injection or aspiration of fluids utilizing 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/K041399
Methodology: https://510kreport.com/methodology