Cleared Abbreviated

K120337 - I-PORT ADVANCE INJECTION PORT (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K120337 · Unomedical A/S · General Hospital

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Feb 2012

Decision

13d

Days

Class 2

Risk

K120337 is an FDA 510(k) clearance for the I-PORT ADVANCE INJECTION PORT. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Unomedical A/S (Osted, DK). The FDA issued a Cleared decision on February 16, 2012 after a review of 13 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Unomedical A/S devices

Submission Details

510(k) Number	K120337 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 03, 2012
Decision Date	February 16, 2012
Days to Decision	13 days
Submission Type	Abbreviated
Review Panel	General Hospital (HO)
Summary	Summary PDF
Third-party Review	Yes - reviewed by an FDA-accredited third party

Regulatory Context

Review time vs. panel average

115d faster than avg

Panel avg: 128d · This submission: 13d

Pathway characteristics

Standards-based clearance path. Third-party reviewed.

Device Classification

Product Code	FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 880.5200

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.