Cleared Traditional

K113469 - NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE

K113469 is an FDA 510(k) clearance for NIPRO HUBER INFUSION, manufactured by Nipro Medical Corporation. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K113469 · Nipro Medical Corporation · General Hospital
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Oct 2012
Decision
331d
Days
Class 2
Risk

K113469 is an FDA 510(k) clearance for the NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on October 18, 2012 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Nipro Medical Corporation devices

FDA 510(k) Submission Details - K113469

510(k) Number K113469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2011
Decision Date October 18, 2012
Days to Decision 331 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
202d slower than avg
Panel avg: 129d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 455
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K113469.
TERUMO(R) NEEDLE
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TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE
K122249 · Terumo (Philippines) Corporation · Aug 2012
COMFORT EZ
K121632 · Simple Diagnostics, Inc. · Aug 2012