# K211634: Hypodermic Needle-Pro EDGE Safety Device

- Pathway: 510(k) (Special)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Aug 26, 2021 after 91 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904198 (1990). 13 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071785: Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with Syringe, Smiths Medical Asd, Inc. (2007) Summary page 4.

## Most influential descendants
- K232943: Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe (2024), 4 descendants of its own
- K242291: SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle (2024), 2 descendants of its own
- K253110: Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (2026), 0 descendants of its own
- K260514: Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle (2026), 0 descendants of its own
- K252814: Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle;  Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe (2026), 0 descendants of its own

## Indications for use
The device is intended for use to inject fluids or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.

Source page: https://510kreport.com/device/K211634
Methodology: https://510kreport.com/methodology