# K014073: Hypodermic Needle-Pro Insulin Syrine & Needle with Needle Protection Device

- Pathway: 510(k) (Traditional)
- Applicant: Portex, Inc.
- Decided: Feb 13, 2002 after 65 days
- Product code: FMF (Syringe, Piston)
- 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011925: Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro Syringe & Needle with Needle Protectio, Sims Portex, Inc. (2001) Summary page 2.

## Indications for use
This device is intended for injection of insulin. The needle protection device covers the needle after use to help prevent needle sticks.

Source page: https://510kreport.com/device/K014073
Methodology: https://510kreport.com/methodology