Cleared Special

K100005 - BD PEN NEEDLE

K100005 is an FDA 510(k) clearance for BD PEN NEEDLE, manufactured by Becton, Dickinson and Co.. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 101-day FDA review.

K100005 · Becton, Dickinson and Co. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
101d
Days
Class 2
Risk

K100005 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 Co. (Franklin Lakes, US). The FDA issued a Cleared decision on April 15, 2010 after a review of 101 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.

FDA 510(k) Submission Details - K100005

510(k) Number K100005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2010
Decision Date April 15, 2010
Days to Decision 101 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
28d faster than avg
Panel avg: 129d · This submission: 101d
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 695
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K100005.
NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')
K093109 · Novo Nordisk, Inc. · Jun 2010
ULTICARE DISPOSABLE PEN NEEDLES
K100812 · Ultimed, Inc. · Jun 2010
CLICKFINE PEN NEEDLE
K100436 · Ypsomed AG · Apr 2010
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
K100209 · Becton, Dickinson & CO · Feb 2010
MICRONJET 600
K092746 · Nanopass Technologies , Ltd. · Feb 2010
FLEXPEN NEEDLE
K090111 · Novo Nordisk, Inc. · Feb 2010
K100005 · BD PEN NEEDLE
Download PDF FDA Summary Becton, Dickinson and…