Cleared Traditional

BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET (K021475) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K021475 · Bd · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2002
Decision
72d
Days
Class 2
Risk

K021475 is an FDA 510(k) clearance for the BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on July 19, 2002 after a review of 72 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K021475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2002
Decision Date July 19, 2002
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 129d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 197
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K021475.
TERUMO SURGUARD 2 SAFETY NEEDLE
K031453 · Terumo Medical Corp. · Jul 2003
MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE
K031200 · Becton, Dickinson & CO · Jun 2003
BD ULTRA-FINE III PEN NEEDLE
K024109 · Becton, Dickinson & CO · Dec 2002
BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET
K011984 · Becton, Dickinson & CO · Aug 2001
TERUMO 30 GAUGE HYPODERMIC NEEDLE
K012646 · Terumo Medical Corp. · Aug 2001
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
K003461 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 2001