Cleared Special

K093309 - PRO-LINE CT (BASIC TRAY) MODEL MR28036101

K093309 is the FDA 510(k) clearance for PRO-LINE CT (BASIC TRAY) MODEL MR28036101 by Medcomp ( Medical Components). It is a Class 2 General Hospital device (product code LJS) cleared through the Special 510(k) pathway after a 33-day FDA review.

K093309 · Medcomp ( Medical Components) · General Hospital
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Nov 2009
Decision
33d
Days
Class 2
Risk

K093309 is an FDA 510(k) clearance for the PRO-LINE CT (BASIC TRAY) MODEL MR28036101. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Medcomp ( Medical Components) (Harleysville, US). The FDA issued a Cleared decision on November 24, 2009 after a review of 33 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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 Medcomp ( Medical Components) devices

Submission Details

510(k) Number K093309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2009
Decision Date November 24, 2009
Days to Decision 33 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
96d faster than avg
Panel avg: 129d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

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