# K073188: Hypodermic Needle-Pro Edge Safety Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Feb 8, 2008 after 87 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). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 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 1.
- K911037: Safety Needle Sheath, Modification, Concord/Portex (1991) Summary page 1.

## Indications for use
This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The EDGE safety device may be removed from the syringe when required by a specific medical procedure.

Source page: https://510kreport.com/device/K073188
Methodology: https://510kreport.com/methodology