Cleared Special

K043397 - MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE

K043397 is an FDA 510(k) clearance for MODIFICATION TO BD ECLIPSE HYPODERMIC N..., 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 19-day FDA review.

K043397 · Becton, Dickinson & CO · General Hospital
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Dec 2004
Decision
19d
Days
Class 2
Risk

K043397 is an FDA 510(k) clearance for the MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE. 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 December 29, 2004 after a review of 19 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 - K043397

510(k) Number K043397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2004
Decision Date December 29, 2004
Days to Decision 19 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
110d faster than avg
Panel avg: 129d · This submission: 19d
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 531
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