Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with Syringe

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K071785 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody Blanket

  Class II

  FDA 510(k) K061513 Active Cleared 1 Aug 2006

• SAF-T Closed Blood Collection System with SAF-Holder Device, Model 99200

  Class II

  FDA 510(k) K072783 Active Cleared 30 Nov 2007

• Thera-Heat Heated Humidifier and Adult Dual and Single Limb Heated Wire Ventilator Breathing Circuits

  Class II

  FDA 510(k) K071958 Active Cleared 21 Nov 2007

• Port-A-Cath Power P.A.C. Implantable Venous Access Systems

  Class II

  FDA 510(k) K093414 Active Cleared 1 Mar 2010

• Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012

  Class II

  FDA 510(k) K092256 Active Cleared 20 Oct 2010

• EchoGlo Needle

  Class II

  FDA 510(k) K171968 Active Cleared 25 Jan 2018

See all devices from Smiths Medical Asd, Inc. →