Cleared Special

K100209 - BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY

K100209 is an FDA 510(k) clearance for BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY, manufactured by Becton, Dickinson & CO. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 25-day FDA review.

K100209 · Becton, Dickinson & CO · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
25d
Days
Class 2
Risk

K100209 is an FDA 510(k) clearance for the BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on February 19, 2010 after a review of 25 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 Becton, Dickinson & CO devices

FDA 510(k) Submission Details - K100209

510(k) Number K100209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2010
Decision Date February 19, 2010
Days to Decision 25 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
104d faster than avg
Panel avg: 129d · This submission: 25d
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 271
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K100209.
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