Cleared Special

K110105 - BD PEN NEEDLE

K110105 is an FDA 510(k) clearance for BD PEN NEEDLE, manufactured by Becton, Dickinson and Company (BD). The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 105-day FDA review.

K110105 · Becton, Dickinson and Company (BD) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
105d
Days
Class 2
Risk

K110105 is an FDA 510(k) clearance for the BD PEN NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (BD) (Franklin Lakes, US). The FDA issued a Cleared decision on April 28, 2011 after a review of 105 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Becton, Dickinson and Company (BD) devices

FDA 510(k) Submission Details - K110105

510(k) Number K110105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2011
Decision Date April 28, 2011
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 272
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K110105.
BD AUTOSHIELD DUO PEN NEEDLE
K110703 · Becton, Dickinson and Company · Jul 2011
K-PACK II NEEDLE- 27G & 30G THIN WALL
K110850 · Terumo Europe N.V. · Jun 2011
K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE
K110527 · Terumo Europe N.V. · Jun 2011
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
K100209 · Becton, Dickinson & CO · Feb 2010
K-PACK II NEEDLE - 29G THIN WALL
K082820 · Terumo Europe N.V. · Oct 2008
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
K073188 · Smiths Medical Asd, Inc. · Feb 2008