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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 686
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K003827.
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VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET
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NOVOFINE 31 DISPOSABLE NEEDLE
K002403 · Novo Norodisk Pharmaceuticals, Inc. · Dec 2000
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K002938 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 2000
K003827 · PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION
Download PDF FDA Summary Bio-Plexus, Inc.