Cleared Traditional

K113470 - NIPRO SAFE TOUCH HUBER INFUSION SET

K113470 is an FDA 510(k) clearance for NIPRO SAFE TOUCH HUBER INFUSION SET, manufactured by Nipro Medical Corporation. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K113470 · Nipro Medical Corporation · General Hospital
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Oct 2012
Decision
330d
Days
Class 2
Risk

K113470 is an FDA 510(k) clearance for the NIPRO SAFE TOUCH HUBER INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on October 17, 2012 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 - K113470

510(k) Number K113470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2011
Decision Date October 17, 2012
Days to Decision 330 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
201d slower than avg
Panel avg: 129d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 770
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K113470.
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NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
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ZYNO MEDICAL ADMINISTRATION SET
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SAFETY SUBCUTANEOUS TISSUE INFUSION SET
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FLOWEASE [SUBCUTANEOUS] INFUSION SET
K121092 · Baxter Healthcare Corp · Jun 2012