Cleared Special

K071998 - ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT

K071998 is an FDA 510(k) clearance for ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT, manufactured by Arrow Intl., Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 65-day FDA review.

K071998 · Arrow Intl., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
65d
Days
Class 2
Risk

K071998 is an FDA 510(k) clearance for the ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on September 26, 2007 after a review of 65 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K071998

510(k) Number K071998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2007
Decision Date September 26, 2007
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
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 263
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K071998.
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BD HYPOINT NEEDLE
K070440 · Becton, Dickinson & CO · Mar 2007
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K063450 · Smiths Medical Asd, Inc. · Jan 2007