Cleared Special

K003827 - PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION

K003827 is an FDA 510(k) clearance for PUNCTUR-GUARD WINGED SET FOR BLOOD COLL..., manufactured by Bio-Plexus, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 28-day FDA review.

K003827 · Bio-Plexus, Inc. · General Hospital
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Jan 2001
Decision
28d
Days
Class 2
Risk

K003827 is an FDA 510(k) clearance for the PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Bio-Plexus, Inc. (Vernon, US). The FDA issued a Cleared decision on January 8, 2001 after a review of 28 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 Bio-Plexus, Inc. devices

FDA 510(k) Submission Details - K003827

510(k) Number K003827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2000
Decision Date January 08, 2001
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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 443
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K003827.
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