Cleared Abbreviated

K071785 - HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE

K071785 is an FDA 510(k) clearance for HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Abbreviated 510(k) pathway after a 31-day FDA review.

K071785 · Smiths Medical Asd, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
31d
Days
Class 2
Risk

K071785 is an FDA 510(k) clearance for the HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY D.... Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Keene, US). The FDA issued a Cleared decision on August 2, 2007 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smiths Medical Asd, Inc. devices

FDA 510(k) Submission Details - K071785

510(k) Number K071785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date August 02, 2007
Days to Decision 31 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 129d · This submission: 31d
Pathway characteristics
Standards-based clearance path.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 454
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K071785.
STERICAN HYPODERMIC NEEDLES
K072247 · B.Braun Medical, Inc. · Nov 2007
GRIPPER MICRO NEEDLE
K072059 · Smiths Medical MD, Inc. · Nov 2007
ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
K071998 · Arrow Intl., Inc. · Sep 2007
BD HYPOINT NEEDLE
K070440 · Becton, Dickinson & CO · Mar 2007
EZ-MIO STERNAL
K063567 · Vidacare Corporation · Jan 2007
PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110
K063450 · Smiths Medical Asd, Inc. · Jan 2007