Cleared Traditional

K052474 - NIPRO HYPODERMIC NEEDLE

K052474 is the FDA 510(k) clearance for NIPRO HYPODERMIC NEEDLE by Nipro Medical Corp.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K052474 · Nipro Medical Corp. · General Hospital
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Nov 2005
Decision
62d
Days
Class 2
Risk

K052474 is an FDA 510(k) clearance for the NIPRO HYPODERMIC NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Nipro Medical Corp. (Lexington, US). The FDA issued a Cleared decision on November 10, 2005 after a review of 62 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.

View all Nipro Medical Corp. devices

Submission Details

510(k) Number K052474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2005
Decision Date November 10, 2005
Days to Decision 62 days
Submission Type Traditional
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
67d faster than avg
Panel avg: 129d · This submission: 62d
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 259
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K052474.
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BD AUTOSHIELD PEN NEEDLE
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K043397 · Becton, Dickinson & CO · Dec 2004
VASCULAR SOLUTIONS SCLERO-KIT
K043019 · Vascular Solutions, Inc. · Dec 2004