Cleared Special

SUPER-FINE PEN NEEDLE (K092016) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K092016 · Stat Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
88d
Days
Class 2
Risk

K092016 is an FDA 510(k) clearance for the SUPER-FINE PEN NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Stat Medical Devices, Inc. (North Miami Beach, US). The FDA issued a Cleared decision on October 2, 2009 after a review of 88 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stat Medical Devices, Inc. devices

Submission Details

510(k) Number K092016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date October 02, 2009
Days to Decision 88 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

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 194
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K092016.
BD PEN NEEDLE
K131358 · Becton, Dickinson & CO · Jul 2013
BD PEN NEEDLE
K123300 · Becton, Dickinson & CO · Jan 2013
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
K100209 · Becton, Dickinson & CO · Feb 2010
STERICAN HYPODERMIC NEEDLES
K072247 · B.Braun Medical, Inc. · Nov 2007
BD HYPOINT NEEDLE
K070440 · Becton, Dickinson & CO · Mar 2007
MEDLINE HYPODERMIC NEEDLES
K062984 · Medline Industries, Inc. · Nov 2006