Cleared Abbreviated

K041399 - HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTE...

K041399 is the FDA 510(k) clearance for HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTE... by Smiths Medical Asd, Inc.. It is a Class 2 General Hospital device (product code FMI) cleared through the Abbreviated 510(k) pathway after a 63-day FDA review.

K041399 · Smiths Medical Asd, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
63d
Days
Class 2
Risk

K041399 is an FDA 510(k) clearance for the HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE. 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 July 28, 2004 after a review of 63 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

Submission Details

510(k) Number K041399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2004
Decision Date July 28, 2004
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 235
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K041399.
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K033575 · B.Braun Medical, Inc. · Feb 2004