Cleared Special

K073210 - MODIFICATION TO: T-PORT HP INFUSION PORT

K073210 is the FDA 510(k) clearance for MODIFICATION TO: T-PORT HP INFUSION PORT by Pfm Medical, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Special 510(k) pathway after a 28-day FDA review.

K073210 · Pfm Medical, Inc. · General Hospital
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Dec 2007
Decision
28d
Days
Class 2
Risk

K073210 is an FDA 510(k) clearance for the MODIFICATION TO: T-PORT HP INFUSION PORT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Pfm Medical, Inc. (Oceanside, US). The FDA issued a Cleared decision on December 12, 2007 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pfm Medical, Inc. devices

Submission Details

510(k) Number K073210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2007
Decision Date December 12, 2007
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 110
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