Cleared Special

K092016 - SUPER-FINE PEN NEEDLE

K092016 is an FDA 510(k) clearance for SUPER-FINE PEN NEEDLE, manufactured by Stat Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 88-day FDA review.

K092016 · Stat Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K092016

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

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 632
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K092016.
FLEXPEN NEEDLE
K090111 · Novo Nordisk, Inc. · Feb 2010
DISPOSABLE HYPODERMIC NEEDLE
K092831 · Feel Tech · Jan 2010
EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO
K091140 · Vidacare Corporation · Oct 2009
AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET
K090117 · Autosafe-Reflex, Inc. · Sep 2009
ISOLYSER SHARPS ROOM SYSTEM, MODEL 800
K090156 · Wcm Waste & Compliance Management, Inc. · Sep 2009
VAKU-8 BLOOD COLLECTION NEEDLES
K090426 · Myco Medical Supplies, Inc. · Jun 2009
K092016 · SUPER-FINE PEN NEEDLE
Download PDF FDA Summary Stat Medical Devices,…