# K011925: Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro Syringe & Needle with Needle Protectio

- Pathway: 510(k) (Traditional)
- Applicant: Sims Portex, Inc.
- Decided: Jul 12, 2001 after 22 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (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). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923127: Needle-Pro Cartridge, Concord/Portex (1993) Summary page 2.

## Most influential descendants
- K024249: Terumo Surguard Safety Syringe (2003), 3 descendants of its own
- K063755: Portex Hypodermic Needle-Pro Fixed Needle Syringe (2007), 2 descendants of its own
- K093176: Med-Lok (2010), 0 descendants of its own
- K072482: Hypodermic Needle-Pro Safety Allergy Tray (2007), 0 descendants of its own
- K014073: Hypodermic Needle-Pro Insulin Syrine & Needle with Needle Protection Device (2002), 0 descendants of its own

## Recalls of this device
- Jun 29, 2004 · Not classified · Z-1078-04: Sterility of product is not assured

## Indications for use
This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The Needle-Pro® device is not designed for use with a luer lock syringe.

Source page: https://510kreport.com/device/K011925
Methodology: https://510kreport.com/methodology