Hypodermic Needle-Pro Insulin Syrine & Needle with Needle Protection Device
by Portex, Inc.
510(k) K014073
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK014073 | Date13 Feb 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Hypodermic Needle-Pro Insulin Syringe & Needle With Needle Protection Device is a medical device designed for the injection of insulin. It consists of a graduated syringe barrel with a permanently affixed needle and an integral, hinged safety sheath that covers the needle after use to help prevent needle sticks.
This device is supplied as a single-use product and is intended for aspiration and injection of U-100 Insulin Only. It is not MRI safe and should be stored according to manufacturer instructions. The device has received FDA 510(k) clearance with product code FMF and is manufactured by Portex, Inc.
Other devices from Portex, Ltd.
Questions
AI-generated answers, 6 Oct 2026
What is the Hypodermic Needle-Pro Insulin Syringe used for?
The Hypodermic Needle-Pro Insulin Syringe is designed specifically for the aspiration and injection of U-100 Insulin only. It features a graduated syringe barrel with a permanently affixed needle and an integral safety sheath that covers the needle after use to help prevent needle sticks.
Is this device single-use or reusable?
This device is supplied as a single-use product and should not be reused. Each syringe is designed for one injection only to ensure sterility and proper functioning of the needle protection mechanism.
What safety features does this insulin syringe have?
The syringe includes an integral, hinged safety sheath that covers the needle after use. This feature helps prevent needle sticks and accidental injuries by enclosing the needle immediately following injection.
How should this device be stored?
The Hypodermic Needle-Pro Insulin Syringe should be stored according to the manufacturer's instructions. It is not MRI safe, so it should be kept away from strong magnetic fields and stored in a clean, dry environment as recommended.