# K063755: Portex Hypodermic Needle-Pro Fixed Needle Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Feb 27, 2007 after 70 days
- Product code: MEG (Syringe, Antistick)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 6 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K904198 (1990). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024249: Terumo Surguard Safety Syringe, Terumo Medical Corp. (2003) Summary page 1.

## Most influential descendants
- K093176: Med-Lok (2010), 0 descendants of its own
- K072482: Hypodermic Needle-Pro Safety Allergy Tray (2007), 0 descendants of its own

## Recalls of this device
- May 17, 2021 · Class I · Z-1798-2021: Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees u
- Jul 10, 2013 · Class II · Z-0642-2014: Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
- Jul 10, 2013 · Class II · Z-0644-2014: Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
- Jul 10, 2013 · Class II · Z-0645-2014: Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
- Jul 10, 2013 · Class II · Z-0643-2014: Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
- Jul 10, 2013 · Class II · Z-0646-2014: Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes

## Indications for use
This device is intended for aspiration and injection of fluids. The needle protection device covers the needle after use to help prevent needle sticks. This device is intended for aspiration and injection of U-100 Insulin Only. The needle protection device covers the needle after use to help prevent needle sticks.

Source page: https://510kreport.com/device/K063755
Methodology: https://510kreport.com/methodology