Cleared Traditional

K012259 - MEDFUSION 2001 & 2010, MODEL N7215IWC

K012259 is an FDA 510(k) clearance for MEDFUSION 2001 & 2010, manufactured by National Custom Ent., Inc.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K012259 · National Custom Ent., Inc. · General Hospital
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Sep 2001
Decision
56d
Days
Class 2
Risk

K012259 is an FDA 510(k) clearance for the MEDFUSION 2001 & 2010, MODEL N7215IWC. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by National Custom Ent., Inc. (Burnsville, US). The FDA issued a Cleared decision on September 12, 2001 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 National Custom Ent., Inc. devices

FDA 510(k) Submission Details - K012259

510(k) Number K012259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2001
Decision Date September 12, 2001
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRZ Device Classification - Class 2, Special Controls

Product Code MRZ Accessories, Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - MRZ Accessories, Pump, Infusion

All 42
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