Cleared Abbreviated

K062984 - MEDLINE HYPODERMIC NEEDLES

K062984 is an FDA 510(k) clearance for MEDLINE HYPODERMIC NEEDLES, manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Abbreviated 510(k) pathway after a 45-day FDA review.

K062984 · Medline Industries, Inc. · General Hospital
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Nov 2006
Decision
45d
Days
Class 2
Risk

K062984 is an FDA 510(k) clearance for the MEDLINE HYPODERMIC NEEDLES. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on November 13, 2006 after a review of 45 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 Medline Industries, Inc. devices

FDA 510(k) Submission Details - K062984

510(k) Number K062984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date November 13, 2006
Days to Decision 45 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
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 455
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K062984.
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K052843 · Busse Hospital Disposables, Inc. · Apr 2006